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DATE: December 29, 2006

It has long been suspected that a high sugar diet over a long term period may lead to an increased risk of developing diabetes. But there has been little or no evidence to support this idea, with studies on the role of any aspect of the diet in the development of diabetes difficult to conduct.

Researchers from the Royal Victoria Hospital at Queens University Belfast Ireland have just published the results of a clinical trial looking at the effects of high sugar intake on insulin resistance (said to be a precursor of Type 2 diabetes) and vascular health in 13 healthy non-diabetic men. Sharing their findings in this months Diabetes journal, Dr Steven Hunter and his team of researchers report that those who received 25% of their calorie intake from sucrose (sugar) as part of a balanced, weight maintaining diet for 6 weeks showed no difference in their degree of insulin resistance, compared to a eucaloric (calorie matched) diet providing 10% of energy as sucrose (control).

In this study, the 25% treatment diet provided on average 200g sucrose per day compared with 80g sucrose from the control (10%) diet (around the average for a British adult).

Dr Hunter of the Royal Victoria Hospital said: Sugar has traditionally been linked to the development of diabetes. These findings challenge that thinking, and show that intakes of more than double that currently recommended do not appear to have an adverse effect on markers of diabetes risk.ť

The study saw 13 healthy men receive either a high-sugar diet (providing 25% of their energy) or a diet providing 10% of their energy as sugar for a period of 6 weeks. After the 6 weeks, subjects crossed over to receive the other treatment for a further 6 weeks. Treatments were separated by a four week wash out period, during which the subjects returned to their usual diet.

The diets for each period were closely matched in overall macro nutrient (carbohydrate, fat and protein) composition. The only difference was in substituting sucrose (sugar) for starch. Insulin resistance was measured by the research gold standard, a two-step glucose clamp.

Furthermore, the high sucrose diet showed no significant adverse effects on a number of other metabolic and physiologic parameters, such as elasticity of the arteries (known as vascular compliance) which impacts on risk of heart disease, and glycaemic profiles.

This study showed that an intake of sucrose two and a half times above average consumption levels showed no adverse effects on this important marker of diabetes risk. This study does not therefore support the notion that sugar intake, within a broad range that covers the intake of the majority of British adults has any adverse effect on the risk of diabetes.

Diet can have a large impact on risk of type 2 diabetes; the strongest evidence for a link exists with saturated fat. Dr Hunter advises that the best way of reducing the likelihood of developing diabetes is through lifestyle changes. He adds it is likely that other dietary factors such as excess calories and lifestyle factors such as physical inactivity and weight gain may be more important than carbohydrate type.ť

In people at risk of type 2 diabetes, a diet rich in carbohydrate and low in fat appears to offer protection against insulin resistance. In addition, being of a healthy body weight and maintaining an active lifestyle will help reduce the risk of developing type 2 diabetes.

Insulin resistance is a common but often silent disorder which occurs when the body does not respond appropriately to the effects of insulin (see below). Insulin resistance can lead to, and is a feature of, the more serious condition, type 2 diabetes (non-insulin dependent diabetes). It is also an independent risk factor for atherosclerotic vascular disease. Any affect of a high sucrose diet on insulin resistance is therefore a reliable indicator of its likely influence on the risk of diabetes and atherosclerosis.

Insulin, a hormone produced by the pancreas, is needed for normal glucose, fat and protein metabolism. Insulin controls the amount of glucose in the blood by enabling glucose to enter cells (e.g. muscle and liver cells) which need glucose for fuel. With insulin resistance the body's cells do not respond fully to the effects of insulin and/or the body cannot produce enough insulin to overcome this defect. This ultimately leads to raised blood glucose. Having blood glucose that is too high (hyperglycemia) is dangerous to health, for example, long-term hyperglycemia is associated with an increased risk of kidney and eye problems.

Fat metabolism is also affected by insulin resistance raising the risk of heart disease, the most common cause of death amongst people with diabetes.

On a global scale, insulin resistance and type 2 diabetes are becoming increasingly common. Whilst genetics account for some degree of susceptibility to these disorders, lifestyle factors such as diet and physical activity levels can have a large impact on risk. Insulin resistance is closely involved in type 2 diabetes, and is thought to be a precursor to the disease.

DATE: December 22, 2006

Sensory nerve cells -- not immune cells -- may be the key culprits in type 1 diabetes, mouse studies suggest.

The findings, if confirmed in humans, would turn diabetes research on its head. They suggest that diabetes could be treated or prevented with drugs that work on the nervous system. The study is published in the Dec. 15 issue of /Cell/; it comes from the labs of Hans Michael Dosch, MD, PhD, and Michael Salter, MD, PhD, at The Hospital for Sick Children in Toronto. "We are now working hard to extend our studies to [type 1 diabetes] patients, where many have sensory nerve abnormalities," Dosch says in a news release. "But we don't yet know if these abnormalities start early in life and if they contribute to disease development."

Most researchers believe type 1 diabetes is a problem with the immune system attacking healthy cells.

These new findings suggest that haywire immune responses are tied to defective sensory nerve cells.

These cells, called TRPV1 neurons, respond to insulin by sending out powerful chemical signals, one of which is a pain-related protein called substance P.

Dosch and Salter's team finds that in diabetic mice, TRPV1 neurons send only a weak signal. When the researchers killed off the mice's TRPV1 cells, the animals' diabetes disappeared. And when they injected the animals' pancreases with substance P, most became diabetes-free. The researchers suggest that defective sensory nerves help start -- and maintain -- diabetes in diabetes-prone humans. "Our observations open new avenues for therapeutic strategies," Dosch, Salter, and colleagues conclude. They also say TRPV1 defects may play a role in other autoimmune diseases.Lupus and rheumatoid arthritis are examples of other autoimmune diseases. An editorial by University of California researchers Helene Bour-Jordan, PhD, and Jeffrey A. Bluestone, PhD, accompanies the Dosch and Salter team's report. Bour-Jordan and Bluestone say the new findings support a growing suspicion among researchers that autoimmune diseases arise from interplays between the nervous system and the immune system. However, they question whether the specific nerve defect seen by the Canadian team is the cause of diabetes, or simply something that happens to people as diabetes progresses.

DATE: December 15, 2006

A Canadian-led research team has uncovered the trigger for Type 1 diabetes, a "breakthrough" that allowed them to cure the disease in mice and could ease the suffering of millions worldwide. "This discovery, a breakthrough that has long been the elusive goal of diabetes research, has led to new treatment strategies for diabetes, achieving reversal of the disease without severe, toxic immunosuppression," the scientists said in a statement.

The findings by researchers at Toronto's Hospital for Sick Children, the University of Calgary and the Jackson Laboratory in Maine were published in the December 15 issue of the journal Cell. Type 1 diabetes is an autoimmune disorder that affects millions of people worldwide, about 10 percent of all diabetes cases. It arises when certain cells responsible for insulin production become inflamed and are ultimately destroyed, making it impossible for the body to produce insulin. Insulin deficiency is fatal and current insulin replacement therapies cannot prevent many side effects such as heart attacks, blindness, strokes, loss of limbs and kidney function. Most studies on Type 1 diabetes had focused on the immune system, but the Canadian-led team found a link between the disease and the nervous system.

The group discovered that abnormal nerve endings in insulin-producing pancreas islet cells sparked a chain of events that caused Type 1 diabetes in mice. When they removed the sensory neurons, it prevented inflammation of the cells and the mice did not develop the disorder. An injection also cleared islet cell inflammation in afflicted mice within a day and normalized the elevated insulin resistance normally associated with the disease. "We have created a better understanding of both Type 1 and Type 2 diabetes, with new therapeutic targets and approaches derived for both diseases," said study collaborator Pere Santamaria of the University of Calgary. "We are now working hard to extend our studies to patients, where many have sensory nerve abnormalities, but we don't yet know if these abnormalities start early in life and if they contribute to disease development." The treatment is now being tested for Type 2 or obesity-related diabetes, in which insulin resistance is even more severe, with "strong evidence" so far it will work, the researchers said.

DATE: December 08, 2006

Half of the estimated 21 million adult Americans with diabetes now rate themselves as having only "fair" or "poor" health, and people between 18 and 44 years of age are increasingly affected, a new report from the U.S. Centers for Disease Control and Prevention finds. In fact, people with diabetes are three times more likely than others to say their health is flagging, the CDC report found.

The news is troubling because "fair or poor health among persons with diabetes is also associated with the presence of diabetes-related complications such as lower extremity amputation, blindness, kidney failure, and cardiovascular disease," noted the editors of the CDC journal /Morbidity and Mortal//ity Weekly Report/, which published the findings last Friday. In the study, CDC researchers looked over 2005 data from the federal Behavioral Risk Factor Surveillance System, an ongoing survey of adult Americans' health and health risk factors. Among the poll's questions: "Would you say that, in general, your health is excellent, very good, good, fair, or poor?" According to the survey, almost half (49.3 percent) of those with diabetes said they were only in "fair" or "poor" health -- a number three times higher than that of people without diabetes. The rate of fair/poor health among people 45 and older with diabetes has remained stable over the past 10 years, hovering around 50 percent. But the CDC noted that health complaints are rising among younger Americans. Among people with diabetes aged 18 to 44, reports of fair/poor health rose from about 36 percent in 1996 to 43.4 percent by 2005, the researchers found.

Race and availability of insurance were also key to health. Hispanic Americans, especially, are 60 percent more likely than whites to note poor health linked to diabetes, and a lack of health insurance boosted the likelihood of poorer health by 70 percent, the study found. Diabetes care is becoming an increasing burden on the U.S. health care system, according to two other government reports released Wednesday. Between 1996 and 2003, the number of adult diabetes patients soared from 9.9 million to 13.7 million, and their individual annual spending on prescription drugs jumped almost 86 percent, from $476 to $883. According to the reports, from the Agency for Healthcare Research and Quality, overall care for patients with diabetes -- including treatment in and out of hospital and for other illnesses such as congestive heart failure -- averaged more than $10,000 annually.

The new diabetes statistics come on the heels of good and bad news from the federal government's annual Health, United States report for 2006, issued earlier in November. That report found that diabetes continues to be a growing threat, especially among older adults. Eleven percent of adults aged 40 to 59, and 23 percent of those 60 and older, have diabetes. The report also focuses on the problem of chronic pain. According to the report, 25 percent of adults say they've experienced pain that lasts at least one day, and 10 percent say they've lived with pain that persists a year or more. "We are living longer, and we have more chronic conditions," said lead author Amy Bernstein, chief of the analytic studies branch at the U.S. Centers for Disease Control and Prevention's National Center for Health Statistics. "Diabetes rates are increasing, obesity rates are increasing. And, as people live longer, they get more chronic conditions, including pain." According to the report, 21 percent of adults aged 65 and older said they had experienced pain in the past month that lasted for more than 24 hours. And almost three-fifths of adults 65 and older said their pain had lasted a year or more.

DATE: December 01, 2006

Researchers reported this week that a substance found in red wine recently shown to help laboratory mice live longer also protects animals from obesity and diabetes.

The new research helps confirm and extend the possible benefits of the substance, resveratrol, and offers new insight into how it works -- apparently by revving up the metabolism to make muscles burn more energy and work more efficiently. Mice fed large doses could run twice as far as normal.

In addition, the scientists produced evidence for the first time linking the biological pathway activated by the substance to humans, showing that the same genetic switch that resveratrol mimics seems to naturally endow some people with faster metabolisms.

"It's very exciting," said Johan Auwerx, professor of medicine at the Institute for Genetics and Cellular and Molecular Biology in Strasbourg, France, who led the research, which is being published in the journal Cell. "This compound could have many applications -- treating obesity and diabetes, improving human endurance, helping the frail. There's a lot of potential."

Auwerx and other researchers cautioned that much more research is needed to study the compound and similar agents, especially to see if the approach is safe for people. Humans would have to take hundreds of resveratrol pills sold in health food stores or drink hundreds of glasses of wine a day to get equivalent levels of the substance tested on the mice, neither of which would be safe.

But the new research adds to growing enthusiasm about the approach, experts said.

"This is the first example of a drug that can apparently affect the whole aging process, not just this disease or that disease, but the mechanisms that allow these diseases to occur," said Felipe Sierra of the National Institute on Aging.

Others agreed.

"The idea of giving someone anything to improve their longevity until very recently would have been considered snake oil or crockery," said Stephen Helfand of Brown University. "But here we are, possibly being able to move out of the laboratory from extending the lives of flies, worms and mice to humans, a lot sooner than we thought."

Resveratrol is found in red wine, grapes and other foods, including peanuts. Scientists suspect it may help explain why French people have fewer heart attacks despite their high-fat diets, and why eating a very low-calorie diet can lengthen the lives of many species.

Researchers recently demonstrated that resveratrol did the same thing for mammals in a study involving laboratory mice. High doses of the compound neutralized the ill effects of a high-fat, high-calorie diet, extending the animals' lives and preventing harm to their livers and hearts.

In the new study, researchers fed mice even higher dosages -- 10 times higher -- along with a high-fat, high-calorie diet. Resveratrol significantly reduced the animals' chances of becoming obese and of developing early signs of diabetes. The mice appeared to experience no harmful side effects.

Additional experiments on the animals' cells indicate the substance works by increasing the activity of an enzyme known as SIRT1, boosting the number and activity of structures inside cells called mitochondria, the researchers said. Mitochondria are like power plants inside cells, burning fat and providing energy. They tend to get revved up by exercise and to deteriorate with age.

The mice fed resveratrol had more efficient muscle tissue, sharply improving their endurance.

"In the elderly, many of the disorders that occur with aging occur because of muscle weakness," Helfand said. "This makes you wonder what would happen if you took an older individual and revved up their mitochondria with resveratrol. You could imagine that it could have a profound positive effect on their health."

Auwerx also wondered whether the substance might be abused by professional athletes. "That could be the illicit use of these compounds -- as performance boosters," he said.

In addition to the mouse experiments, the researchers also produced evidence supporting the theory that SIRT1 plays a key role in longevity in humans in an accompanying analysis of 123 Finnish adults. The subjects born with certain variations of the SIRT1 gene had faster metabolisms, naturally burning energy more efficiently, indicating the same pathway works in humans, too.

"We've all seen people who are thin no matter what they eat or do -- that have good metabolisms versus bad. This may help explain that," said Christoph Westphal, chief executive of Sirtris Pharmaceuticals of Cambridge, Mass., which sponsored and helped conduct the study as part of its effort to develop drugs based on the approach.

The company is already testing a potent version of resveratrol on diabetic humans and hopes to eventually test it and similar compounds as a treatment for a variety of diseases. "We are targeting a gene that controls the aging process," Westphal said. "Many diseases have a link to the aging process. So these kinds of drugs clearly have the potential to treat several diseases of aging."

Other researchers said the new work is interesting but remained cautious, particularly about making the link to SIRT1.

"I think that's part of the story, but that it would be a mistake to think that's all that's going on," said Matt Kaeberlein of the University of Washington.

DATE: November 24, 2006

People with type-2 diabetes can learn life skills for daily management of their disease during a free online workshop and study.

Without proper management, diabetes can lead to such complications as cardiac problems, high blood pressure, strokes and kidney failure.

The online workshop Self-Management @ Stanford: Healthier Living with Diabetes lasts for six weeks. Participants in the study will be followed for two years to determine how effective the Internet can be in helping people learn skills to manage their diabetes. It is hoped that participants will improve their blood pressure, cholesterol, blood glucose and weight. The investigators will also be looking for improvements in quality of life, exercise and depression.

The study is organized by the Stanford University School of Medicine’s Patient Education Research Center, which has been developing tools for chronic disease self-management for 20 years. Dr. Kate Lorig, a professor of medicine and a nurse who has long been involved in developing and monitoring patient self-management programs, is the principal investigator on the study. Lorig’s team said that diabetes patients often don’t get enough help from their primary health-care providers; they explain that their workshops are intended to complement instructions from patients’ physicians.

By teaching self-management skills to an audience online, researchers are aiming to reach people who are unable to attend community classes or who might not be interested in in-person gatherings. Participants need to be adults living in the United States with a physician-confirmed diagnosis of type-2 diabetes, who have Internet access and who have an e-mail account. Participants may not have received treatment for cancer in the past year or be pregnant.

During the six weekly workshops, two trained, lay facilitators, who also have diabetes, will moderate online groups of about 25 people with type-2 diabetes. Participants are asked to log on, at their convenience, two or three times each week for a total of less than two hours weekly. Sessions are highly interactive through e-mail, messaging and online discussion boards, but participants do not need to log on at the same time.

Workshop topics include: blood glucose management; healthy eating; understanding A1C, lipids, body mass index and blood pressure numbers; weight control; exercise; hypoglycemia; managing sick days; working with health-care providers, and managing emotions and relationships.

Participants will be randomly assigned to one of three groups: those who receive the workshop; those who receive the workshop and participate in a yearlong e-mail discussion group, or those in a control group who receive the usual care. All three groups will complete four online questionnaires about their health status; members of the control group will also receive a gift certificate after completing each questionnaire, as well as a copy of the book used in the workshop at the end of the two-year period.

To register for the workshop, go to the Self-Management @ Stanford page.

For more information, call 800-366-2624 or send e-mail.

Workshops are also being offered specifically for Native Americans who are living with diabetes. Click here for Registration for Native American workshops.

The study is funded by grants from the National Institutes of Health and the Robert Wood Johnson Foundation.

DATE: November 17, 2006

Joslin Diabetes Center, global leader in diabetes research, care and education, announced today a new free educational tool on its Web site – the Staying Healthy with Diabetes video series. The set of six short videos gives people with diabetes important information about the regular tests they need to have done to live a healthier life. Several of Joslin’s internationally recognized physicians are featured in these videos.

The number of Americans with diabetes approaches 21 million, and now 54 million Americans have pre-diabetes. Joslin’s Web site continues to be a key resource for those affected by the disease, providing an online diabetes library and the latest information about diabetes research and care at Joslin. The video series, which adds new audio-visual educational materials to Joslin’s Web site, gives details about the importance of incorporating these six tests into standard diabetes care.

"At Joslin, we believe that active participation through self management and empowerment form the key to successful treatment of diabetes," explains Martin Abrahamson, M.D., Medical Director at Joslin Diabetes Center. "These videos give people with diabetes details about what the six tests measure and guidelines on what the results should be. This allows patients to work closely with their healthcare team to achieve their personal goals and stay healthy with diabetes."

Click on the links below for information about the six tests:

• A1C Test: Presented by Dr. Martin Abrahamson – The A1C test reflects the average blood glucose level for a two to three month period prior to the test and measures how well diabetes is being controlled. Joslin recommends people with diabetes have an A1C done every three to six months, achieving a level of 7 percent or lower, while also checking blood glucose levels at home on a daily basis. Dr. Abrahamson states, Controlling blood glucose levels through A1C tests and home blood glucose monitoring are critical to staying healthy and avoiding the serious consequences of diabetes-related complications, including heart disease, eye disease and kidney failure."
• Blood Pressure Test: Presented by Florence M. Brown, M.D., Co-Director, Joslin and Beth Israel Deaconess Medical Center Diabetes and Pregnancy Program – Monitoring blood pressure levels is critical for people with diabetes. Joslin recommends blood pressure levels be taken at every doctor’s office visit, with a target of 130/80 mmHg or better, and if kidney complications from diabetes have already developed, the target should be at or below 125/75 mmHg. "Diet, exercise, losing weight, minimizing stress, and reducing salt and caffeine intake all have a positive effect on blood pressure levels," emphasizes Dr. Brown.
• Eye Exam: Presented by Deborah K. Schlossman, M.D., Ophthalmologist, Beetham Eye Institute at Joslin Diabetes Center – Diabetic retinopathy is the most common sight-threatening eye disease for people with diabetes, but vision loss due to diabetic retinopathy can be prevented in the majority of cases. Joslin recommends a three-prong approach to eye care: maintain excellent A1C levels; keep blood pressure and other health factors in check; and have an annual eye exam involving either pupil dilation (where the doctor places drops in the eyes) or specially validated photographs of the retinas (the back of the eyes). "Although there are a variety of treatments for diabetic retinopathy, the earlier it is diagnosed and care begins, the more effective the treatment," she advises. Even if there are no eye or vision problems, an eye exam should be performed yearly to monitor eye health and determine the best follow-up care or treatment.
• Foot Exam: Presented by Richard A. Jackson, M.D., Senior Physician, Joslin Diabetes Center – Poorly controlled diabetes can cause circulation problems and also can cause neuropathy, or damage to the nerves leading to a loss of feeling or sensation. Joslin recommends people with diabetes have their feet examined at least once a year for altered sensation, decreased circulation and/or infection. "Smoking has a huge impact on the likelihood of people with diabetes developing foot complications because it affects circulation and causes nerve damage," notes Dr. Jackson.
• Kidney Function Test: Presented by Robert C. Stanton, M.D., Chief of Nephrology, Joslin Diabetes Center – Diabetes is a leading cause of kidney failure across the globe. Joslin recommends an annual microalbumin urine test to detect the presence of protein or albumin. Patients also should have creatinine levels monitored and a GFR, or estimated glomerular filtration rate, calculated for early signs of kidney disease. "Twenty to 40 percent of people with diabetes develop kidney disease, but when diagnosed early and treated, patients have better odds for healthy kidneys," explains Dr. Stanton.
• Lipid Levels Test: Presented by Om P. Ganda, M.D., Director of the Lipid Clinic, Joslin Diabetes Center – Because research indicates that high levels of lipids, or blood fats, increase the risk of heart disease, Joslin recommends people with diabetes have their lipid levels screened at least once a year. Joslin recommends an LDL level of less than 100; for people with a history of heart disease, stroke or cardiovascular disease, an LDL of 70 or less is advised. Dr. Ganda comments, "People with diabetes need to get the LDL, or bad cholesterol, level as low as possible because it is the most important factor causing cardiovascular disease."

DATE: November 10, 2006

Yogurt enriched with fruit or made from soy could play an important dietary role for people living with Type 2 diabetes and high blood pressure, suggests new findings by University of Massachusetts Amherst researchers.

Led by Kalidas Shetty, the UMass Amherst scientists screened extracts from a sampling of dairy and soy yogurts for properties that could help keep diabetes and hypertension in check, such as the activity level of enzymes that help moderate blood glucose levels. The researchers found that fruit-enriched yogurts—especially those made with blueberries or made from soy—contain active natural compounds that may curb some aspects of diabetes, the researchers report in an upcoming issue of the /Journal of Food Biochemistry/. The findings provide a strong rationale for further clinical studies, and for incorporating “healthy diet design” into disease management strategies, says Shetty. “What one eats should be part of an overall approach to therapy,” he says. Doctoral students Emmanouil Apostolidis and Young-In Kwon collaborated with Shetty on the research.

Type 2 diabetes, which accounts for roughly 90 percent of U.S. cases, is often associated with obesity, high blood pressure and elevated levels of cholesterol. The disease is characterized by an abnormal rise in blood sugar right after a meal. This chronic high blood sugar, known as hyperglycemia, is associated with many of the complications that can arise from the disease, including the failure of various organs such as the kidneys, heart, eyes and problems with nerves and blood vessels.

Medications that prevent the spike in blood glucose often target certain enzymes—in particular, enzymes that are responsible for modifying carbohydrates before they can be absorbed by the small intestine. Carbohydrates are the major source of blood sugar and inhibiting these carb-altering enzymes—alpha-amylase and alpha-glucosidase—slows the body’s absorption of sugars. The researchers were also interested in a third enzyme—angiotensin-I converting enzyme or ACE-I—which plays a role in the constriction of blood vessels. Medications known as ACE inhibitors block the activity of this enzyme, and such medications are used in treating high blood pressure in both diabetic and non-diabetic patients. Such medications have been shown to be an effective strategy for diabetes management, yet they can have unwanted side effects, says Shetty. Previous research by Shetty and others found that certain plant compounds also play a role in blocking all three of these enzymes, opening up the possibility that foods rich in such compounds may provide health benefits, but without the adverse side affects, he says.

So Shetty and his team went to the local supermarket and bought peach, strawberry, blueberry and plain yogurts made by four different brands, including a soy brand. The researchers took samples of each yogurt, and tested their ability to inhibit each of the enzymes of interest, using water or a buffer solution as a control. Of all the sampled yogurts, soy yogurt enriched with blueberries packed the most punch, inhibiting the activity of all three enzymes tested, the researchers report. Peach and strawberry enriched yogurts also fared well in their ability to inhibit the carb-altering enzymes alpha-amylase and alpha-glucosidase. The researchers also tested the yogurts for antioxidant activity and the quantity of a group of plant chemicals known as phenols. Phenols and polyphenols are found in a wide variety of plants; they give red wine and tea their heart-healthy boosts and are especially prominent in dark-colored fruits and vegetables. The benefits of these compounds seem to come from their antioxidant powers—polyphenols scavenge cells for nasty free radicals such as reactive forms of oxygen. Free radicals can damage cellular machinery much the way that metal is turned to rust. The extracts from blueberry yogurts had the second-highest concentrations of phenols and the most antioxidant activity, the researchers found, beat out only by soy (even the plain soy yogurt had higher phenol content than any regular yogurt with fruit). The blueberry extracts also were the best at blocking the action of alpha-glucosidase, which was correlated with the amount of phenols.

There was much more variation in which extracts inhibited alpha-amylase and ACE-I, and it wasn’t necessarily correlated with phenol content says Shetty. Soy yogurts had the highest phenol content overall, and were the best at inhibiting ACE-I. A growing body of research indicates that diets rich in fruits and vegetables are associated with lower incidences of certain diseases, and plant compounds such as phenols are of increasing interest to scientists, says Shetty. How these dietary antioxidants mediate disease isn’t clearly understood, Shetty suspects that they stimulate the body’s own antioxidant enzymes to shift into a defense mode that protects tissues from chronic disease, many of which are associated with damaging free radicals. “The numbers of people with environment-related diseases are going through the roof,” says Shetty, noting that in the United States alone more than 20 million people are estimated to have diabetes. Worldwide estimates are that 170 million to 200 million people have diet-linked Type 2 diabetes, and the World Health Organization expects those numbers to double by the year 2030. “Poor communities and especially Native Americans are afflicted with Type 2 diabetes more than other communities,” say Shetty. "Cost-effective dietary changes are essential for fighting this disease, and traditional diets that have a higher content of these protective antioxidants are an important part of the solution. We should be able to use diet along with other therapies, and diabetes is a disease where this especially makes sense."

DATE: November 03, 2006

Fifty-four million Americans - that’s one in six of us -- have pre-diabetes and most don’t even realize it. Mark Schutta, MD, medical director of the Penn Rodebaugh Diabetes Center, is urging at-risk patients to be proactive and ask your doctor to give you a simple blood test for pre-diabetes - to arm yourself with information before the damage is done. It means you have blood glucose levels that are higher than normal and you could one day reach a high enough level that you would be diagnosed with having diabetes.

Diabetes is a disease that affects the body's ability to produce or respond properly to insulin and must be managed on a daily basis once diagnosed. If not, it can lead to several health complications including death. November is designated annually as American Diabetes Month.

“If you have pre-diabetes, there’s a 75% probability that you will develop diabetes within 30 years,” comments Schutta. “Our country is in the middle of a type 2 diabetes epidemic. Right now, if you’re born in the U.S., your risk of developing diabetes is one in three.”

Schutta says the reason for the high numbers is that diabetes is a “silent killer” and in the early stages of the disease, patients often have no symptoms. Schutta urges anyone at risk for diabetes to be screened. He adds, “If you knew you had pre-diabetes, you could still prevent getting diabetes through changes in diet and exercise. There are many health benefits to knowing you have pre-diabetes and ‘heading it off.’ If you wait until you have diabetes, the vascular damage to your body may already be done.”

You should be screened for pre-diabetes if:
• You have a known family history of diabetes.
• You are African American, Latino, Native American, Asian American or Pacific Islander.
• While pregnant, you developed gestational diabetes.
• You delivered a baby who weighed more than nine pounds.
• You have high blood pressure, high blood cholesterol, are overweight.

Diabetes is a chronic disease affecting more than six percent of the U.S. population or 21 million people. Diabetes is linked to heart and kidney disease, strokes and other serious health problems. Diabetes results when the body either does not produce insulin or cannot use it properly. Insulin is a hormone that your body needs to convert sugar, starches, and other food into energy for living. Although there is no cure for diabetes, it can be controlled.

DATE: October 27, 2006

Carrying two copies of a common variant of a particular gene doubles your chances of developing diabetes and puts you in a similar risk category to being clinically obese, according to a collaborative study led by UCL (University College London) researchers.

The collaborative team led by UCL Professor Steve Humphries studied the TCF7L2 gene, which was discovered to be implicated in diabetes earlier this year by a group working in Iceland. The new study followed healthy middle-aged men in the UK for 15 years, and found that carrying a common variant of the gene increased their risk of developing diabetes by 50 per cent. Carrying two copies of the variant gene increased the risk two-fold, to nearly 100 per cent. In the population as a whole, the impact of this gene on the risk of developing diabetes is as big as the problem of being clinically obese (having a body mass index over 30).

The study, published in the Journal of Molecular Medicine, also looked at White, Indian-Asian and Afro-Caribbean diabetes patients and found that the risk for carriers of the gene was essentially the same across all groups.

Professor Steve Humphries, of the UCL Centre for Cardiovascular Genetics, said: "Although being overweight is the major risk factor for developing diabetes, it is now becoming clear that an individual's genetic makeup has a big impact on whether or not they are going to develop diabetes.

"This is the first study that has followed healthy men and shown that carrying this risk gene has such a big effect. Because it is so common, and because the risk is so high, this gene seems to be causing as many cases of diabetes in the UK as obesity, which we know is the biggest risk factor.

"Our findings point to a whole new genetic mechanism which could be putting people at high risk of diabetes, and this needs to be explored. If we could understand more about this pathway, it could be possible to develop completely new treatment methods.

"In future it might be possible to use this genetic information to identify those at high risk, but the most important things to do to avoid becoming diabetic are to eat healthily, take moderate exercise and not to become overweight."

Currently, over two million people in the UK have diabetes and another 750,000 have diabetes but are unaware of it. People with diabetes are much more likely to develop heart disease and may also have other medical problems which can lead to kidney disease and blindness.

Scientists are not yet certain of the full role of the TCF7L2 gene, but it appears to be involved in switching on and off a host of other important genes, and is probably key in the pancreas (where insulin is made to control the sugar levels in the blood), as well as in fatty tissue and the gut. The actual mutation in the gene has not yet been found, and there are likely to be several different mutations acting in different people.

It is possible that this gene could become a therapeutic target, although it would be important to target TCF7L2 only in the specific tissue necessary to reduce risk of diabetes - for example, in the insulin-making cells of the pancreas. Treatment would need to be designed to avoid interfering with the gene's important functions in other tissues, which could otherwise cause unwanted side effects.

In terms of genetic screening, it might be useful in the future to include this gene in a panel of other genes that have important effects on risk of diabetes, if people carrying TCF7L2 variants were found to need a certain drug. Such an approach is already being piloted in a form of diabetes that starts in early adulthood (MODY), where different genes cause the disease and require different treatments.

Dr Angela Wilson, Director of Research at Diabetes UK which partly funded the study, said: "The findings of this research are very exciting, as Type 2 diabetes results from a complex mix of genetic and lifestyle factors.

"If we can improve our understanding as to why people with certain genes are more likely to develop diabetes, it will help us to find ways to identify those at risk with a view to enabling them to take preventative action by adopting a healthy diet, becoming active and ensuring they do not become overweight - which is a major risk factor for diabetes.

"It also opens up new avenues of research which have the potential to lead to new treatments for people with diabetes."

DATE: October 20, 2006

A new pill just might help people lose weight by taking the edge off the cravings that make dieting so painful. And an added bonus, lower blood pressure, blood glucose, and cholesterol levels as well. The drug, rimonabant, fights the drive to overeat by blocking receptors in the brain that bring on the "munchies" when they're activated by natural appetite-regulating chemicals. (As it happens, the chemicals behave a lot like marijuana, and their discovery in the 1990s was prompted by earlier research into how pot works in the body.) Rimonabant was approved in June for use in the European Union, where it goes by the name Acomplia. Manufacturer Sanofi-Aventis hopes for approval in the USA by the end of this year.

Besides helping to control appetite, the body system that rimonabant acts upon plays a role in regulating weight and the breakdown of glucose and fat, as molecules called endocannabinoids bind to receptors in fat, muscle, the gastrointestinal tract, and the liver. The system's many functions may explain why people taking rimonabant see improvement in a range of risk factors for heart disease and diabetes-their blood glucose, their cholesterol readings-that can't be explained by weight loss alone. "There's a growing body of evidence that in obesity the system is overactivated," says Louis Aronne, a professor at Weill Cornell Medical Center in New York who has studied rimonabant. "What we're doing with this treatment is to try to tone it down to a normal level."

One hitch: Side effects reported include anxiety and depression. Some experts worry that the trials haven't looked at people who were depressed before starting the drug. "You could make the argument that a lot of obese people have an increased tendency to be depressed," says Stephen Woods, a professor of psychiatry and director of the Obesity Research Center at the University of Cincinnati. "How the drug will affect the obese person who's depressed is an unknown."

DATE: October 13, 2006

Merck & Company is expecting government approval any day now of a new diabetes drug with potential annual sales of $750 million.

Januvia is designed to treat Type 2 diabetes by lowering blood sugar levels and, unlike other diabetes treatments, causes very few side effects.

“There really doesn't seem to be any downside to it,” says John Buse, president-elect of the American Diabetes Association, “whereas all the other drugs out there have some downside to them.”

However, Buse said, some other diabetes treatments appear to be more effective than Januvia in lowering blood sugar levels.

Merck officials dispute that assessment, arguing that Januvia is as effective as other treatments.

“We believe that Januvia is very efficacious,” said Dr. John Amatruda, vice president of clinical research for Merck.

Diabetes, a disease characterized by high blood sugar levels, afflicts nearly 21 million Americans, and was the sixth-leading cause of death in the U.S. in 2002. It is caused by a lack of insulin, a hormone that helps convert sugars, starches and other nutrients into energy. Diabetes can lead to stroke, heart disease, blindness, kidney failure, amputations and death.

Type 2 diabetes is the more common form, accounting for 90 percent to 95 percent of U.S. cases. Unlike Type 1 diabetes, which requires insulin injections, many people with Type 2 can control their blood sugar levels with diet, exercise and medications.

Januvia is one of a new class of drugs called dipeptidyl-peptidase 4 (or DPP-4) inhibitors, which work by enhancing the body's own ability to lower blood sugar, or glucose, when it is elevated, according to Merck.

“The mechanism of action of DPP-4 inhibitors is distinct from that of any currently available class of glucose-lowering agents,” Merck said in Januvia informational materials.

“Because they work through a different mechanism ... all [who suffer from diabetes] could benefit from this drug,” said Buse.

Januvia's FDA approval has been slated for “mid-October,” meaning approval is, “imminent, any day now,” said Jay Galeota, general manager of Merck's global diabetes franchise. Januvia was developed in Rahway, N.J., and will be produced in Italy. But it will be sold by Merck's Upper Gwynedd-based sales force.

Merck is not the only company expecting approval of a DPP-4 inhibitor. Novartis is developing a DPP-4 inhibitor called Galvus, which is expected to hit the market next year.

Both drugs show promise but both face the challenge of a long learning curve with diabetes patients and healthcare professionals, wrote a group of Goldman Sachs analysts headed by James Kelly in an April report.

“We ... remain upbeat on the opportunities for this product class and estimate sales of Galvus and Januvia in 2010 of $1.4 billion and $750 million respectively,” the Goldman analysts wrote.

Merck's 2005 sales were more than $22 billion. Some of its larger drugs generate billions in annual sales.

Prudential Equity analyst Tim Anderson is not making specific sales predictions but wrote in a July report that Januvia has “high commercial potential.”

Buse thinks the jury is out on whether practitioners will prescribe Januvia over other drugs that he said confer a greater benefit but have greater side effects. “To me, at least, it's completely unclear whether this is going to be a blockbuster drug that millions will take,” Buse said.

Amatruda said Januvia was tested on people with “mild to moderate” cases of diabetes. In those cases, in which patients blood sugar levels were 8 percent or less, Januvia reduced those levels by about eight-tenths of a percent. But in trials on people with blood sugar levels above 9 percent, it reduced blood sugar by as much as 1.4 percent, Amatruda said.

In head-to-head trials against Glipizide, a frequently used diabetes medication, Januvia caused side effects including hypoglycemia in only 4.9 percent of patients, compared to 32 percent for Glipizide, Amatruda said.

“It's very powerful in lowering glucose [blood sugar], but it has a side effect profile that's similar to a placebo,” said Amatruda.

DATE: October 06, 2006

Short or poor quality sleep is associated with reduced control of blood-sugar levels in African Americans with diabetes, report researchers from the University of Chicago in the latest issue of the Archives of Internal Medicine. The finding suggests that one inexpensive way to improve the health of patients with type 2 diabetes might be to improve the duration and quality of their sleep.

“Sleep is modifiable,” said Kristen Knutson, research associate (assistant professor) in the department of health studies at the University of Chicago and first author of the paper. “We've known for some time that skimping on sleep can impair glucose tolerance even for healthy people. Now we have evidence connecting chronic partial sleep deprivation and reduced blood-sugar control in patients with diabetes.” “Although we can't be certain whether sleep loss makes diabetes worse or the diabetes interferes with sleep, it only makes sense for everyone, but especially patients with diabetes, to give themselves the opportunity to get enough sleep,” Knutson said. The study focused on 161 African-American patients being treated at the University of Chicago Hospitals for type 2 diabetes. The researchers asked participants how much sleep they thought they needed at night and how much sleep they managed to get on weeknights and weekends. They also assessed the quality of their sleep using a standard 19-item questionnaire, the Pittsburgh Sleep Quality Index (PSQI).

To assess blood sugar control they measured glycosylated hemoglobin, a standard tool for management of patients with diabetes. Glycosylated hemoglobin, or HbA1c, reflects the average blood glucose level over the previous three months. A normal HbA1c result is between four and six percent. Higher levels represent poor glucose control. Patients with diabetes are considered to be under good control if they can keep their levels below seven percent. The researchers found that, on average, the 161 diabetes patients got very little sleep and had poor glucose control. Mean sleep duration was six hours a night. Only six percent reported getting eight hours of sleep on weeknights and only 22 percent reported getting at least seven hours. Seventy-one percent had poor sleep quality. The median HbA1c score was 8.3 percent. Many patients with diabetes have painful complications that can interfere with sleep. Even after the researchers excluded 39 patients who reported such pain, however, two out of three of the remaining 122 patients reported poor quality sleep. The average HbA1c among those patients was almost as high: 8.2 percent. Insufficient or poor quality sleep was closely associated with higher HbA1c results. For patients with no complications of their diabetes, a three-hour “perceived sleep debt”-the difference between how much sleep they felt they needed and how much they think they got-was associated with a 1.1 percentage-point increase in HbA1c levels, for example from 7.5 percent up to 8.6 percent.

For patients with at least one complication of diabetes-such as nerve pain, kidney damage or coronary artery disease-decreased sleep quality appeared to be more important. An increase of five points (out of 21) on the PSQI was associated with a 1.9 percentage-point increase in HbA1c, for example from 8.7 percent up to 10.6 percent. “The magnitude of these effects,” the authors note, “is comparable to those of widely used oral antidiabetic agents.” A long series of laboratory and epidemiologic studies has suggested that cutting back on sleep has a harmful effect on glucose control, insulin secretion and metabolism in ways that might increase diabetes risk, said Eve Van Cauter, professor of medicine at the University of Chicago and senior author of the study. The current study asks the question: is glucose control in subjects who already have diabetes adversely affected by too little sleep or poor sleep? "Our findings suggest, at least in this study population, that short or poor sleep is associated with decreased blood-sugar control in patients who already have diabetes," she said. "The growing tendency to burn the candle at both ends may be a significant contributor to the current epidemic of diabetes. One way to slow down this epidemic may be to avoid building a chronic sleep debt."

The MacArthur Foundation, the American Diabetes Association and the National Institutes of Health funded this study. Additional authors are Armand Ryden, of the University of Chicago, and Bryce Mander, now at Northwestern University.

DATE: September 29, 2006

In a large-scale test, transplanted pancreas cells eliminated the need for insulin in some diabetes patients, but for many the benefit was short-lived.In many cases where the treatment was initially successful, too many transplanted cells eventually stopped working. The authors of the study, published in the New England Journal of Medicine, said refining their methods should improve the success rate. Chief study author James Shapiro of the University of Alberta in Edmonton, Canada, said the transplanted cells seemed to stop working because not enough survived the initial transplant. "We've only got a small number of cells that end up engrafting and they're all having to work at maximum capacity," Shapiro said. "When an engine runs at 3,000 revs every minute of the day and doesn't get a break, eventually some of them start to burn out."

The technique, originally announced in 2000, has become known as the Edmonton protocol. This was the first international test of the method, to see if it could successfully be applied on a large-scale basis. It was designed to help people with Type 1 diabetes, an autoimmune disease that destroys the pancreas cells that produce the insulin needed to process blood sugar. Type 1 diabetes affects up to 2 million Americans. Processed pancreas cells from dead donors were given to 36 patients in North America and Europe. The treatment was tested in "the worst of the worst" patients, Shapiro said. A year later, 44 percent no longer needed insulin because the injected cells were processing blood sugar properly. Another 28 percent needed significantly less insulin. But at the two-year mark, 11 of the 16 patients who responded best were back on insulin. "Analyzed another way, 58 percent of subjects reached insulin independence at some point during the trial, but 76 percent had become insulin-dependent again by two years after transplantation," Jonathan Bromberg and Derek LeRoith of the Mount Sinai School of Medicine in New York wrote in a Journal editorial.

The study shows that more research is needed before this technique approaches the success rate of a regular pancreas transplant, they said. When a patient receives the entire organ instead of processed cells, the success rate is 50 to 70 percent after five years, Bromberg and LeRoith said. Both techniques carry risks because patients must take drugs that suppress the immune system and can have serious side effects. It is now clear that "institutions all over the world can successfully perform the protocol with at least short-term results that are promising," they said. "The problem remains that the medium- to long-term results are not durable, so much more work is needed." However, they said, the technique has come along way. Before Shapiro and his colleagues achieved a one-year survival rate of 80 percent for their transplanted pancreas cells, the success rate had been less than 2 percent.

An article By Gene Emery

DATE: September 15, 2006

Type 1 diabetes develops when your pancreas stops making insulin, what the body needs to break down sugar. Nobody knows why this happens, and there's no cure for it. Patients rely on taking insulin, but now, doctors say a drug could make that a thing of the past.Last year at this time, Ohio native Kaitlin Walsh-Reed was taking off on a plane for a trip to Florida. But today, the 17-year-old's plane landed 800 miles north, outside Indiana University School of Medicine in Indianapolis.

It's not exactly a vacation, but Kaitlin makes the trip every few weeks for medical care. She was diagnosed with type 1 diabetes four months ago. "When I first heard that I had it, I thought it was something like really bad," she recalled. "I was kind-of scared." Kaitlin's part of a new study on a drug called Rituximab. It targets the body's B-cells, which could preserve any insulin-producing cells a newly-diagnosed patient still has or even jump-start insulin production. "It has implications both in terms of prevention as well as achieving a cure," explained pediatric endocrinologist Dr. Henry Rodriguez, of Indiana University School of Medicine. "That they can find a cure for diabetes... I would love it," she said, but for today, Kaitlin's happy to just be going home.Rituximab is currently used to treat lymphoma, rheumatoid arthritis, and other autoimmune diseases. If the drug is effective for diabetes, it could reduce some of the long-term problems linked to it, like heart disease, vision loss and kidney damage. But researchers aren't there yet. In the meantime, Kaitlin will continue checking her blood sugar levels before each meal and keep careful records of her calories and carbs. But she hopes someday, she won't have to. "That they can find a cure for diabetes... I would love it," she said, but for today, Kaitlin's happy to just be going home. Rituximab is currently used to treat lymphoma, rheumatoid arthritis, and other autoimmune diseases. If the drug is effective for diabetes, it could reduce some of the long-term problems linked to it, like heart disease, vision loss and kidney damage.

BACKGROUND: According to the American Diabetes Association, type 1 diabetes, formally known as juvenile diabetes, is usually diagnosed in children and young adults and develops when the pancreas stops producing insulin. Insulin is necessary for the body to be able to use sugar. Sugar is the basic fuel for the cells in the body, and insulin takes the sugar from the blood into the cells. Patients must monitor their blood sugar levels by taking blood tests multiple times a day and take insulin through injections or inhalants, as there is no cure for the disease. In healthy people, a normally functioning pancreas monitors blood sugar consistently and delivers just the right amount of insulin to keep that blood sugar within the normal range.

UNDER STUDY: In a new international clinical trial led by doctors at the Indiana University School of Medicine in Indianapolis, patients who have been diagnosed with type 1 diabetes within the last three months are candidates, as they are still in the "honeymoon" phase of the disease. This refers to a patient still having between 10 percent and 30 percent of insulin-producing cells left. In this new study, patients are given injections of the B-cell targeting drug rituximab (Rituxan) in the hope that this honeymoon phase can be prolonged. Diabetes is easier to manage in this period, but ultimately, doctors hope it could lead to a cure. The first step would be preserving any insulin cells a patient has left and potentially make him or her less susceptible to some of the long-term consequences associated with the disease, such as heart disease, circulatory problems, vision loss, and kidney damage. The next step would be finding a way to stimulate the re-growth of insulin-producing cells, which would in essence produce a cure. One of the studies leaders, pediatric endocrinologist, Henry Rodriguez, M.D., says: "If we can determine that there is a means to safely prevent the immune system from destroying those insulin-producing cells, then, we then have something that we can take to those individuals that are at risk for developing the disease. Hopefully, at that point, we would have the situation where we could better identify individuals who are at risk and treat them with a safe therapy that would prevent them from developing diabetes to begin with." He adds, "This a therapy that has a potential of revolutionizing how we treat type 1 diabetes, whether or not we screen for it, outside of a research study, whether we can prevent it. So it has implications both in terms of prevention as well as achieving a cure. That is what I'm excited about."

RITUXIMAB: Doctors are essentially trying to alter the immune system so that it no longer recognizes insulin-producing cells as being foreign. Patients in the study receive rituximab weekly during the first four weeks of their participation in the study and will then be followed for two years -- and likely for a number of years after that. Doctors are looking for a primary outcome of a preservation of the ability to make insulin a year out. They will enroll 66 patients over two years at 15 centers. The study is funded by TrialNet ( http://www.diabetestrialnet.org )

DATE: September 08, 2006

It may soon be possible to manage the serious condition of diabetes naturally using nutmeg seeds (Myristica fragrans) according to new research presented this week at the British Pharmaceutical Conference in Manchester England.

Diabetes is a metabolic disorder that is estimated by the Department of Health to affect 2.35 million people in England alone, and this figure continues to rise. Diabetes is a serious condition by which the body is unable to break down sugar (glucose) in the blood due to a deficiency of insulin. People with diabetes often have raised fat (lipid) levels in the blood, which increases the risk of cardiovascular disease.

Nutmeg has been used across the world as a ground spice in cooking for centuries. In the tribal areas of India, where there is a lack of access to conventional medicine, nutmeg is also used for treating diabetes, as well as other ailments such as diarrhea, mouth sores, and insomnia. But to date there has been no scientific data to support its anti-diabetic activity.

Knowledge of nutmeg's traditional use led pharmacists in Pune and Sagar, India, to study nutmeg scientifically. Their controlled tests on rats showed that extracts of the spice:

• significantly decreases blood glucose levels
• improves the lipid profile in the blood
• stimulate the beta-cells of the pancreas to release insulin
• improves body and organ (liver and pancreas) weight

Somani, says that the research team now want to carry out some advanced studies to see how nutmeg can be used in the treatment of this common disease, possibly with an international partner.

DATE: September 01, 2006

People with diabetes might be able to reduce their blood sugar by using a cinnamon extract, a new study has found.

The number of people being diagnosed with adult-onset (type 2) diabetes has grown to about 150 million people worldwide, with more than 17 million in the United States. People with diabetes have high blood sugar levels because their cells don’t respond to insulin, the hormone that signals when glucose (the form sugar takes in the blood) needs to be stored. Over time, the extra glucose in the blood damages tissues.

Eating a high-fiber, low-sugar diet and exercising are important ways to keep blood glucose levels normal. Oral medications are also often used to reduce blood glucose levels, and in some cases insulin injections are necessary. Nutritionally oriented healthcare providers frequently recommend minerals such as chromium and magnesium. Some herbs such as gymnema and fenugreek have been found to have blood glucose–lowering effects.

Cinnamon (Cinnamomum cassia) is an aromatic herb with sweet and warming qualities. Its history as a medicinal herb goes back centuries in India and other parts of Asia, but it is better known in the Western world as a culinary spice. Animal studies and preliminary studies in humans have suggested that cinnamon has blood glucose–lowering effects that could help people with type 2 diabetes.

In the latest study, published in the European Journal of Clinical Investigation, 65 people with diabetes being treated only with diet or oral medications (not insulin) were given either a cinnamon extract (equivalent to 3 grams of cinnamon per day) or a placebo for four months.

Fasting blood glucose levels (measured after eight or more hours without eating or drinking) dropped 10% in those who used the cinnamon, but did not change in the placebo group. Blood glucose levels decreased the most in those who had the highest levels at the beginning of the study.

“More and more people are being diagnosed with type 2 diabetes, and many of them want to avoid oral medications and especially insulin injections,” said Linda Dacey, MD, who practices internal medicine. “Although the findings from this study are encouraging, for now it seems wise to wait until future research clarifies whether cinnamon works well enough to be used as a first-line treatment, along with diet and exercise, or whether it should be used in conjunction with oral medications.”

In the meantime, cinnamon is a safe and inexpensive addition to a program designed to help manage high blood sugar from diabetes.

Maureen Williams, Who received her bachelor’s degree from the University of Pennsylvania and her Doctorate of Naturopathic Medicine from Bastyr University in Seattle, WA. She has a private practice in Quechee, VT, and does extensive work with traditional herbal medicine in Guatemala and Honduras.

DATE: August 18, 2006

Reducing the size of abdominal cells, a risk factor for diabetes and heart disease, takes more than cutting calories, according to new research published on Wednesday by Wake Forest University. Early results show that exercise should be added to the equation, according to the study.

"The message is very clear," said the lead author Tongjian You, Ph.D., "Exercise is important to reducing the size of these cells, and may one day be part of a prescription for treating the health complications associated with abdominal fat." The study is reported in the August issue of the International Journal of Obesity. The results -- from 45 obese, middle-age women with excess abdominal fat -- are part of an ongoing study of up to 125 women. The goal is to determine what lifestyle changes are needed to reduce the size of abdominal fat cells. It is well known that overall obesity is risk factor for diabetes and heart disease. Obese people who have more abdominal ( an apple shape) are at a higher risk than people who store excess fat in their hips and thighs (a pear shape).

Abdominal fat is associated with metabolic syndrome, a cluster of symptoms that increases the risk for heart disease and diabetes. The current research studied a lesser-known risk factor for the syndrome -- the size of fat cells just under the surface of the skin, known as subcutaneous fat. Earlier studies had shown that exercise can reduce fat cell size, but it is not known if the intensity of exercise matters during dietary weight loss. For the current study, all women had a deficit of 2,800 calories a week, either through dieting or a combination of dieting and exercise. One group cut their calorie levels through diet, but did not exercise. A second group walked at about 1 to 2 miles per hour on a treadmill for 50 minutes three times a week. A third group also walked three times a week, but at 3.5 to 4 miles per hour for 30 minutes. Both exercise groups burned 400 calories each week through walking. The diet-alone group had no changes in abdominal fat cell size. However, both exercise groups had decreases of about 18 percent in the size of their abdominal fat cells. "These early findings do point to the importance of exercise in treating the complications of abdominal fat," Dr. You said.

DATE: August 11, 2006

BATON ROUGE, LA -- Results from a new study in patients with type 2 diabetes demonstrate that daily supplementation with 1000 mcg of chromium as chromium picolinate, in combination with a common oral anti-diabetic medication, improves insulin sensitivity and glucose control better than the oral anti-diabetic agent alone.

The study, conducted by researchers at Pennington Biomedical Research Center (PBRC) and the University of Vermont College of Medicine, is published in the August issue of Diabetes Care, an official journal of the American Diabetes Association.

The study also found that chromium picolinate significantly reduced the weight gain typically associated with the use of a commonly prescribed antidiabetic medication.1 These findings are significant as more than two-thirds of people with type 2 diabetes are not at the suggested goal for their blood sugar. Additionally, more than 80 percent of people with type 2 diabetes are overweight, which can significantly increase their risk of disease-related complications, including cardiovascular disease, which is the leading cause of death amongst patients with diabetes.

"The results further support that chromium may serve as a safe and effective adjunct to medication in helping people with type 2 diabetes improve their blood sugar control. In patients who take a sulfonylurea to control elevated blood sugar, weight gain is common. However, the study findings show that weight gain was less with use of supplemental chromium," said study investigator, William Cefalu, MD, chief of the Center's Division of Nutrition and Chronic Diseases. "Also important is that chromium picolinate helped reduce abdominal fat accumulation, which is associated with a greater risk for other conditions such as abnormal lipids and hypertension."

The 40-week randomized, double-blind, placebo-controlled, study was designed to examine the effect of adding daily chromium picolinate supplementation to an antidiabetic medication.1 Sulfonylurea, a commonly prescribed treatment for type 2 diabetes, was given to 29 subjects for 24 weeks, in conjunction with chromium picolinate or a matching placebo (sugar pill).1

Blood sugar levels of study participants taking chromium picolinate in combination with the antidiabetic medication dropped significantly compared to the group taking the medication plus placebo (-31.00 + 7.37 mg/dL vs. -11.33 + 8.03 mg/dL).1 In addition, insulin sensitivity, as measured by glucose disposal, for participants taking the medication along with chromium picolinate was increased when compared to those taking the antidiabetic agent and placebo.

Study participants taking chromium picolinate also experienced significantly lower abdominal body fat accumulation than the group taking medication and placebo, and experienced less overall weight gain (0.9 kg vs. 2.2 kg).1

"It's also important to note that no significant adverse events were reported among the study participants," added Cefalu.

The chromium used in this study was provided by Nutrition 21, the makers of Chromax® chromium picolinate.

DATE: August 04, 2006

Fatty acids commonly found in dairy products have successfully treated diabetes in mice, according to a researcher at Penn State. The compounds, known as conjugated linoleic acids (CLA), have also shown promising results in human trials, signaling a new way of potentially treating the disease without synthetic drugs. "The compounds are predominantly found in dairy products such as milk, cheese and meat, and are formed by bacteria in ruminants that take linoleic acids – fatty acids from plants – and convert them into conjugated linoleic acids, or CLA," says Jack Vanden Heuvel, professor of molecular toxicology in Penn State's College of Agricultural Sciences and co-director of Penn State's Center of Excellence in Nutrigenomics.

Researchers first became interested in CLA when it was shown to inhibit a variety of cancers such as breast, skin and colon in mice, and further research showed effects on circulating cholesterol and inflammation. These effects are the same as the newest generation of synthetic drugs used to treat diabetes in humans. These synthetic drugs act by triggering a set of nuclear receptors called PPAR. In addition to being targets for a variety of clinically effective drugs, PPARs belong to a large family of proteins, and their biological purpose is to sense fatty acids and fatty acid metabolites within the cell, says Vanden Heuvel. When the synthetic drugs interact with these protein receptors, it turns the receptor "on," making it an active form of the protein, which then interacts with DNA and regulates gene expression. This increases the enzymes that process fatty acids and also increases the tissues' sensitivity to insulin.

"We wondered if CLA was using the same mechanism, in which case it could be used as an anti-diabetes drug," Vanden Heuvel says. To test the idea, he used CLA on mice prone to adult onset (Type-2) diabetes. Results indicated that the mice had an improvement in insulin action, and a decrease in circulating glucose. Also, the mechanism was indeed similar to that of the drugs. "Anti-diabetes drugs act the same way. They mimic the natural activators of the receptors by getting into the cell and interacting with the PPARs to regulate glucose and fat metabolism," says Vanden Heuvel. Early human trials indicate that when administered for longer than 8 weeks, CLA improves the body's misregulation of insulin and lowers the level of glucose in the blood in patients with adult onset, or Type-2 diabetes, the most common form of this disease. However, Vanden Heuvel cautions that while having a diet that is high in dairy and meat products, and thereby CLA, might have a health benefit, one must also be aware of other lipids present in these products, such as trans fatty acids. Instead, he suggests that in addition to a well-balanced diet, it is advantageous to incorporate CLA as a dietary supplement, or to seek out new products that enrich foods such as butter, margarine and ice cream with CLA. "Adult-onset diabetes is fast becoming an epidemic and is largely associated with poor diet and nutrition and other lifestyle issues," Vanden Heuvel says. The reason for the increase in diabetes may have to do with the ratio of so-called "good" and "bad" fats, with the average American diet containing too much of the "bad" fats. CLA, whose effect is very similar to fish oil, a source of "good" fat, could prove beneficial against Type-2 diabetes. "And compared to the synthetic drugs used to treated this disease, CLA does not cause weight gain and may in fact decrease overall body fat," says Vanden Heuvel, who has been granted a patent on the new method of treating diabetes with CLA. Other researchers on the patent include Martha Belury, Ohio State University, and Louise Peck, University of Washington, for the work initially conducted at Purdue University. The Penn State Center of Excellence in Nutrigenomics is at nutrigenomics.psu.edu.

DATE: July 28, 2006

A British research institute will be allowed to recruit women having fertility treatment to donate eggs for stem cell research and therapeutic cloning. In exchange for their eggs, the Human Fertilization and Embryology Authority (HFEA) said on Thursday the institute would contribute to the cost of the patients' treatment. "We have made an offer of a license to Newcastle Fertility Center at Life which, if the conditions are accepted by the research team, would allow them to carry out an egg-sharing' scheme in which women who are already undergoing fertility treatment can donate some of their eggs for use in research in return for some of their treatment costs being met," said Angela McNab, the chief executive of the HFEA.

Therapeutic cloning involves creating early embryos to obtain stem cells -- master cells in the body that can develop into any other cell type -- to treat diseases. At present, only spare embryos left over from fertility treatments are used in stem cell research and scientists have been concerned about a shortage of eggs for research. Stem cell researchers hope the HFEA move will speed up progress toward therapies for illnesses such as diabetes, Alzheimer's and Parkinson's disease.

"The potential benefits of stem cell research in the treatment of degenerative diseases is so great that the prospect of increased availability of good quality eggs obtained via 'egg-sharing' is to be welcomed," said Dr Gillian Lockwood of the British Fertility Society. Therapeutic cloning is condemned by anti-abortion groups because it involves removing the stem cells and destroying the embryo. The egg-sharing scheme is not expected to be operating for at least 12 months while regulatory agreements and funding details are finalized. The HFEA made the offer to the center ahead of the start of a three-month consultation period that will begin in September during which it will consider views on the egg-sharing issue. There has been some concern about how scientists will obtain eggs for research, and fears women could be pressured into donating eggs or that their health could be put at risk. "We have made the offer on the understanding that the center will provide regular information to the HFEA on its progress. "The Newcastle team are also aware that should new policy be made as a result of the public consultation that the license committee are able to review the amendment to their license," McNab added in a statement.

By Patricia Reamey

DATE: July 21, 2006

As Congress and U.S. President George W. Bush squared off over stem cell research, potential treatments for diabetes, spinal cord injuries and other devastating disorders are still years away from human testing. How fast scientists can do key experiments to prove whether embryonic stem cell research will live up to its promise depends on how much money the federal government contributes, the key question as the Senate opened debate Monday on legislation to loosen Bush's restrictions. At issue is not whether human embryonic stem cell research will proceed or even if taxpayers will help fund it - they already do, $38 million US worth this year. The question boils down to exactly which embryonic stem cells are used in the race to develop treatments.

A limited number were created before 2001, many in ways that make human use problematic if not impossible. But there are potentially thousands of newer cells, culled from fertility clinic leftovers otherwise destined to be thrown away. Many scientists insist these would be better suited for implantation into sick Americans. Embryonic stem cells are essentially master cells, able to morph into all the cell types found in the body. If scientists could learn to control these cells and coax them into becoming specific types on demand, they potentially could grow replacements for damaged tissue - new insulin-producing cells for Type 1 diabetics or new nerve connections to restore movement after spinal injury, for example. The controversy revolves around the fact that scientists take those cells from a five-day-old embryo, when it's a ball of about 100 cells barely visible without a microscope, and the culling kills the embryo. Bush likened that to abortion when, on Aug. 9, 2001, he restricted government funding to research using only the embryonic stem cell "lines" then in existence, groups of stem cells kept alive and propagating in lab dishes. The new legislation, which passed the Senate but was vetoed by Bush, wouldn't fund the creation of new stem cell lines - nor any embryo destruction - but would let the National Institutes of Health fund research using newer stem cells in the pursuit of treatments.

Five states are funding embryonic stem cell research themselves. California voters approved a $3 billion initiative now being fought in court. Connecticut has a 10-year, $100-million initiative. Illinois spent $10 million last year. Maryland has approved a $15-million budget and New Jersey has spent about $25 million in two years. In the Senate, opponents argued against the need to work with embryonic cells, saying adult stem cells found in various tissues, such as blood-producing stem cells in bone marrow or umbilical cord blood, provide an embryo-free alternative. "We do not need to treat humans as raw material," Sen. Sam Brownback, R-Kan., said Monday. "It is immoral for us to do it." Scientists are avidly studying adult stem cells, too, with roughly $200 million in financial aid from the NIH this year, far more than for embryonic stem cells. But despite 50 years of research so far, adult stem cells' main use today is for bone marrow transplants to counteract intense cancer chemotherapy or to treat only a handful of other disorders, researchers wrote in the journal Science last week. "The politicians kind of set us up against each other but . . . the scientists are not arguing about this. We are working together," University of Minnesota stem cell researcher Meri Firpo said in an interview. She has worked with all types and created two of the Bush-approved embryonic stem cell lines and 11 newer lines with private money. Added Dr. Harold Varmus, a Nobel laureate and former NIH director: "I do believe in the very long run it will be possible to learn enough about how cells change their behaviour to take perhaps any kind of cell and make it do anything." But that's harder to do and could take far longer, while the first embryonic stem cell studies in people might begin within five years, he added.

So what are the biggest hurdles for embryonic stem cells? They involve both science and paperwork, and Minnesota's Firpo embodies both: -In her quest to develop insulin-producing cells to treat diabetes, she runs one lab for her NIH-funded research and a separate lab for research funded by her university and private groups, even though both labs do the same studies. Because private grants are smaller than NIH's multiyear grants, her privately funded experiments go into the freezer when that money runs out and she has to raise more. -Firpo created her newer stem cells in ways safer for transplantation. When she created her two Bush-approved batches, "we never thought these cell lines would be used clinically," she explained, describing how basic researchers don't follow the Food and Drug Administration's rules for actual therapies. -Scientifically, researchers are reporting great strides in getting embryonic stem cells to form the tissues they want. The question is whether they'll continue to work properly when implanted into the body, a big safety question. "They need to stay in the right place, stay alive and need to function correctly. Those are the parts we're just beginning with," says Firpo. "It's hard to predict what timeline that's going to take."

Source: Lauran Neergaard

DATE: July 07, 2006

Keith Szymkowiak had been going to a treatment center for four hours of dialysis three times a week after kidney failure almost seven years ago. His life centered around trips to Wisconsin's Gundersen Lutheran's dialysis centers. But during the past four months, Szymkowiak has found freedom with a new type of do-it-yourself dialysis at home. The 55-year-old Onalaska diabetic is the first in the La Crosse area to use a new system of home dialysis, which provides shorter, more frequent and possibly even more effective treatments. The treatments -- which last for two hours a day, six days a week -- more closely mimic his kidneys' natural functions and ease many of the side effects that come with traditional dialysis. Szymkowiak said he now gets a chance to choose his time for dialysis, but more importantly, he feels like his life has been transformed. "Now it feels like my kidneys are actually working," Szymkowiak said. "I have more energy, and I feel so much better. I don't think I could go back to regular dialysis. "Everyone's flabbergasted at how well I'm doing."

Home dialysis has been around for many years, but the dialysis machines have been big and cumbersome and required special plumbing, said Dr. Wilfrido Yutuc, a kidney specialist at Gundersen Lutheran for more than 40 years. Yutuc said home dialysis is starting to gain popularity as technology makes it easier for patients to treat themselves at home. At the forefront of the movement are medical device-makers, such as NxStage of Massachusetts, that have developed equipment that's simple enough for patients to operate and fits in their homes. The method is hemodialysis, which runs the blood from the patient's body through a dialysis machine and back again to clean the blood. NxStage broke ground last year with its introduction of a 75-pound machine for home dialysis. It looks like a 13-inch TV set, uses standard electrical outlets and doesn't need special plumbing connections or permanent installation. More than 100 dialysis centers in the U.S. now offer NxStage's system. Szymkowiak is now one of three Gundersen Lutheran patients on the system. "It's portable dialysis," Yutuc said. "You can take it with you for the weekend or vacation, and you set the time for dialysis. It fits easy into one's lifestyle, and patients gain more independence." Patients also have better control of their blood pressure, often reduce the number of medications and may not be hospitalized as often because the home dialysis system may help prevent complications, Yutuc said. Szymkowiak already has seen the health benefits. His blood pressure is lower, and he has reduced the number of medications he takes from more than 30 to nine. High blood pressure is Szymkowiak's enemy because he has major heart problems.

Szymkowiak was diagnosed with type I diabetes in 1980 and took six to eight insulin shots a day until four years ago when he received an insulin pump, a small device programmed to automatically and continuously deliver small amounts of insulin around the clock. In December 1999, Szymkowiak was ill and ended up in a Texas hospital, where he was diagnosed with kidney failure. He later was treated for several heart attacks and a stroke. He moved to La Crosse in 2001 and continued dialysis at Gundersen Lutheran. Szymkowiak said he is not eligible for a kidney transplant due to his heart problems. He will be on dialysis for the rest of his life. "The saying goes that nobody dies from kidney failure," Yutuc said. "I've had one patient who was on dialysis for 24 years. You die from other things such as stroke or heart attack." Szymkowiak plans his home dialysis treatments around his wife's work schedule. In late afternoon, he takes about 40 minutes to prepare for his treatment. The dialysis machine sits in a basement room equipped with a stereo and video system. He opens bags of dialysis solution and sets up the tubing and accessories he'll need for that day's treatment. When his wife, Shirley, comes home from work, he inserts needles into his arm, and he's ready for dialysis. Szymkowiak passes the time on a couch watching TV or movie, or listening to music. The dialysis machine has alarms to signal a malfunction or improper setup, and help is only a phone call away, he said. He is preparing to take his dialysis machine on the road for a week -- supplies will be sent to his destination. Szymkowiak had about a month of training before he started his treatment at home. "Learning how to set up the machine is not that hard," Szymkowiak said. "It becomes routine after a while." But Yutuc said, "Not everyone is a candidate for home dialysis. They have to have confidence in themselves and feel comfortable with the setup." Jane Brodrick, a Gundersen Lutheran registered nurse, said people who are successful at home dialysis often have a supporting partner. "They're also not afraid to do the setup and feel they can handle it," she said. Jane Welch, another Gundersen Lutheran registered nurse, helped Szymkowiak with his home dialysis machine. "Keith is doing very well and is committed to make it work," Welch said. Szymkowiak said he's always trying to buy more time with his life, and home dialysis makes his life easier. "I'm on borrowed time already," he said. "God had six chances to take me, and I'm still here. I'm going to enjoy it as along as I can."

For patients with kidney failure, there are just three options to filter toxins from their bodies and replace some of the organs' functions. Without those treatments, they would die. Peritoneal dialysis, which uses the body's own peritoneal membrane inside the abdomen to remove impurities. It can be performed at home but must be done every day and is feasible only for certain patients. About 8 percent of dialysis patients use this method, according to the most recent federal data available. Gundersen Lutheran has about 25 patients using this method of home dialysis. Hemodialysis, which runs the blood from the patient's body through a dialysis machine and back again. The treatment cleans the blood, but many patients feel wiped out. Typically, patients visit a clinic three times a week for four-hour sessions. Hemodialysis also can be done at home. Kidney transplant can offer some patients greater freedom, with fewer diet restrictions than the other treatments. But organ recipients have to take medicine to prevent rejection of the kidney, and there's a shortage of donor kidneys. About 130,000 patients had transplanted kidneys in 2003, according to federal data.

Sources: McClatchy Newspapers and Gundersen Lutheran Medical Center

DATE: June 30, 2006

Millions of diabetics face a lifetime of daily injections to replace the insulin their bodies fail to produce, as well as a host of risks that includes blindness, amputation, kidney failure, and heart disease. For many, particularly those afflicted with juvenile diabetes, transplants of the pancreatic tissue in which insulin is produced might alleviate these problems. Unfortunately, there are not nearly enough organ donors available for transplantation.

Insulin-producing pancreas tissues from animals could potentially provide a nearly unlimited supply for transplantation. But until now, attempts to transplant such animal tissues into non-human primates have evoked a fierce immune response. However, embryonic tissues, such as those from pigs (in which the insulin-producing cells are similar to those of humans), might not be rejected as strongly. New research by Prof. Yair Reisner of the Weizmann Institute's Immunology Department in Rehovot Israel, has brought the possibility of transplants from pig embryos one step closer. The results of the study appeared in the June issue of PLoS Medicine.

In previous work, Reisner and his team had shown that each embryonic organ has its own "time window" during which the chances for successful transplantation are optimal. Prior to this window, the early tissue's cells, which are still largely undifferentiated, can give rise to tumors. Past the window, however, they may be too well-developed: The host identifies these cells as foreign, causing the body to reject them. By transplanting tissues from pig embryos into mice lacking proper immune systems, they determined that the best time frame for pancreatic tissue was about a third of the way through gestation (from 42 to 56 days).

In the new study, Reisner's team wanted to see if such tissues could function in the body. They first implanted embryonic pancreatic tissue from pigs into mice that lacked an immune system of their own, but had human immune cells injected into them. From this experiment they learned that tissues taken at 42 days (within the time frame they had previously determined) exhibited a markedly reduced immune response.

Next, the team tried the experiment on mice with fully functioning immune systems, but destroyed the insulin-producing cells in their pancreases before proceeding with the transplant. With the aid of relatively mild immune suppression protocols, the implanted tissues were fully functional over time, producing insulin and maintaining the mice's blood sugar at normal levels.

"The results of this study," says Prof. Reisner, "warrant further, pre-clinical research on primate models."

Prof. Reisner is the incumbent of the Henry H. Drake Professorial Chair in Immunology, and his research is supported by numerous grants and private trusts including the J & R Center for Scientific Research.

DATE: June 23, 2006

Having just celebrated its first on-air anniversary, dLife TV, FOR YOUR DIABETES LIFE! has walked away with no less than four prestigious Telly Awards, including two top honors.

dLife TV, a LifeMed Media Company, is an innovative and pioneering television series dedicated to empowering the millions of Americans living with diabetes. The weekly talk/magazine format show delivers leading experts, timely medical information, inspirational stories and recipes for healthy eating. This ground-breaking television show strives to produce timely information motivating patients as well as their families, friends and caregivers.

Founded in 1978, the Telly Awards has become the premier award honoring outstanding local, regional, and cable TV commercials and programs, as well as the finest video and film productions. Winners and finalists represent the best work of the most respected television production companies, television stations, cable operators, and corporate video departments throughout the world.

A prestigious judging panel of over 25 accomplished industry professionals upholds the historical standard of excellence that Telly represents. Judges evaluate entries to recognize distinction in creative work.

dLife scooped up two bronzes and two silvers, the silvers being the highest recognition possible.

Top Telly honors went to dLife's "The Story of Insulin" in the documentary category and to "Diabetes Epidemic/Diabetes Research/Diabetes and Kidney Complications" in the health & fitness category.

dLifeTV airs every Sunday evening on CNBC, 7:00PM ET, 6:00PM CT and 4:00PM PT, every Sunday morning on DIRECTV channel 251, 7.30AM ET; and six days a week on CoLours TV on DISH TV Channel 9407.

dLife TV is produced by LifeMed Media, the first multimedia healthcare communications company created to serve chronic disease populations. Its flagship venture, dLife -- For Your Diabetes Life is the first integrated media network targeting the estimated 21 million people living with diabetes and their caregivers, families, friends and those at risk of developing diabetes -- some 80 million in all. dLife provides knowledge, insight, advice and inspiration to this group through dLifeTV, dLife.com, dLifeRadio and dLifeConnect. For further information about dLife visit www.dlife.com

DATE: June 16, 2006

Diabetes is a tough disease to manage – primarily because it requires a heavy dose of self-management – so anything that makes that management simpler is likely to get significant uptake. That concept is emerging as an overriding theme, perhaps even more so than in the past, at this year’s 66th annual scientific sessions of the America Diabetes Association (Alexandria, Virginia) ongoing in Washington.

Thus, Eli Lilly (Indianapolis) and Alkermes (Cambridge, Massachusetts) are riding the main wave as they rolled out at the meeting new studies which push forward the potential commercialization of their combined work: administration of a Lilly insulin product delivered by Alkermes’ AIR Inhaled System.

Additionally, Lilly was demonstrating its HumaPen Memoir, an electronic pen injection device with a feature that “remembers” previous doses of insulin.

Lily and Alkermes are hoping that they can be the second to offer an inhaled insulin product, following the approval, this past January (Medical Device Daily; Jan. 31, 2006), of Exubera, the first inhaled insulin product developed jointly by Pfizer (New York) and Nektar Therapeutics (San Carlos, California), with analysts saying that together, and perhaps even separately, inhaled insulin will reach the high ground of “blockbuster” sales status.

The new safety studies position Lilly and Alkermes to develop a product that can be used by those with both diabetes and breathing problems – asthma and chronic obstructive pulmonary disease (COPD), an application that was recommended against by the FDA panel reviewing Exubera, according to Doug Muchmore, senior medical scientist, Medical Fellow II, for Lilly.

He told Medical Device Daily that Pfizer and Nektar had supplied some study information to the FDA panel concerning safe use of Exubera in cases of COPD, but that the studies by Lilly and Alkermes are the first to be published and showing safety in these uses. Continued positive results, he said, would likely be used to seek the broader indications for the AIR system.

Thus, the studies reported on at this year’s ADA meeting were not broad-based but focused narrowly on the use of the system in COPD.

Muchmore told MDD that the company also has just completed enrollment of pivotal Phase II safety study, noting this as a “major milestone” in the companies’ clinical development programs for the AIR/insulin combination.

He declined offering timelines for regulatory filings or potential commercialization of the product given “the complexities and interactions” of what is required.

In the collaboration, Muchmore said Lilly is supplying the bulk insulin product – an unmodified human insulin, chemically identical to human insulin – and then providing a range of expertise for the trials.

The role of Alkermes has been to reformulate the insulin for the inhaler device and do the packaging into blister packs and foil pouches.

He described the special formulation as having two key characteristics: large particle composition of the insulin, but with low density, so as to need low energy to get into the lungs. Together, these features enable, for the insulin product, “a high level of consistent dose delivery [requiring only] regular breathing.”

The studies reported at the ADA meeting take into account that 10 million people in the U.S. – according to the National Heart, Lung, and Blood Institute (Bethesda, Maryland) – have COPD and that it may be a risk factor, particularly among women, for developing Type 2 diabetes.

Klaus Rave, MD, of Profil Institute for Metabolic Research (Neuss, Germany), said, “Because of COPD’s prevalence and its potential correlation with Type 2 diabetes, particularly in women, it’s important to study the safety, efficacy and predictability of AIR insulin in many patient populations, including in people with compromised lung function.”

Specifically, the studies analyzed the effect, in Type 1 and Type 2 diabetes, of these patients’ COPD on inhaled insulin absorption and action; the importance to patients of simple, patient-directed training of an inhaled insulin system; and dosing flexibility with the AIR insulin system.

The company’s Phase I study, “Pharmacokinetics (PK) and Glucodynamics (GD) of Human Insulin Inhalation Powder (HIIP) in Subjects with Chronic Obstructive Pulmonary Disease (COPD),” is, according to Lilly and Alkermes, the first published analysis of the effect of COPD on inhaled insulin absorption and action. Designed to evaluate the impact of compromised lung function on inhaled insulin dose delivery, the study found that the absorption and action of AIR insulin was reduced by a consistent amount in the presence of COPD.

The results also demonstrate that AIR insulin was able to deliver similar results on different days in patients with or without COPD and was “generally well-tolerated.”

In this open-label, randomized, three-period crossover trial, pharmacokinetic and glucodynamic responses to AIR insulin were compared with subcutaneous insulin lispro in 15 non-smoking healthy subjects (mean age 38) and 30 non-smoking subjects with moderate COPD – 15 each with chronic bronchitis (mean age 53) and emphysema (mean age 58) – using standard glucose clamp methodology, a process for measuring the absorption of and an individual’s response to insulin.

Subjects received two single doses of AIR insulin and one dose of subcutaneous insulin lispro. Pharmacokinetic and glucodynamic measures were assessed using blood tests, and safety was assessed using pulmonary function tests (PFTs) before and after each clamp and by spirometry, performed four times during clamps.

Key results: Total insulin exposure and metabolic effect after subcutaneous insulin lispro were comparable in all three groups. Compared with healthy subjects, AIR insulin absorption was reduced by 22% in subjects with emphysema and by 44% in those with chronic bronchitis. The metabolic effect of the AIR insulin dose was reduced in emphysema subjects and chronic bronchitis subjects.

AIR insulin was well-tolerated by these patients, measurements showing no difference between AIR insulin and subcutaneous insulin lispro treatments, with modest decreases in forced expiratory volume and forced vital capacity in both COPD groups.

A poster presentation, “A Comparison of Standard vs. Intensive Training on Usage of the Human Insulin Inhalation Powder (HIIP) Delivery System in Type 2 Diabetes (T2D) Patients,” reported on a Phase II trial in people with Type 2 diabetes, designed to compare two levels of training intensity, either standard/patient-directed training, or intensive/provider-coached training for the AIR insulin system on overall blood glucose levels.

Key results: the AIR insulin system is easy to use and can be supported by simple, patient-driven training while helping patients manage blood sugar levels. Both training methods had similar rates of compliance with training directions, and similar safety profiles. AIR insulin exposure was also similar between groups.

Besides other studies focusing on key attributes of the AIR insulin system, Lilly was demonstrating its HumaPen Memoir device, the term “memoir” referring to the device’s ability to provide the time, date and amount of the last 16 insulin doses delivered. Looking very much like a standard fountain pen, the device features a small clear viewing window at one end providing the information via digital display.

The HumaPen can inject from one to 60 doses of Humalog from a small cartridge. Humalog is the flagship insulin from Eli Lilly, introduced by Lilly as the world’s first insulin analog. Humalog can be taken within 15 minutes before or immediately after a meal, enabling patients to adjust the dose according to when they eat, what they eat and how much they eat.

FDA-approved – and in use in Europe for several years – the HumaPen will get commercial rollout in the U.S. this fall, according to Lily.

SOURCE-Medical Device Daily

DATE: June 09, 2006

Scientists at Johns Hopkins have uncovered a surprising and novel way of lowering blood sugar levels in mice by manipulating the release of sugar by liver cells. The results, published in the June issue of Cell Metabolism, have implications for treating conditions like diabetes.

The discovery by researchers in Hopkins' Institute of Basic Biomedical Sciences and McKusick-Nathans Institute for Genetic Medicine reveals that a protein called GCN5 is critical for controlling a domino-like cascade of molecular events that lead to the release of sugar from liver cells into the bloodstream. Understanding the role of GCN5 in maintaining blood sugar levels is leading to a clearer picture of how the body uses sugar and other nutrients to make, store and spend energy. "Understanding the ways that energy production and use are controlled is crucial to developing new drugs and therapies," says the report's senior author, Pere Puigserver, Ph.D., an assistant professor of cell biology at Hopkins. The inability to properly regulate blood sugar levels leads to conditions like obesity and diabetes. Both type 1 and type 2 diabetes cause blood sugar levels to stay too high, which can lead to complications like blindness, kidney failure and nerve damage.

"Diabetes is a really big problem, even when patients are given insulin and stay on strict diets," says Carles Lerin, Ph.D., a postdoctoral fellow in cell biology at Hopkins and an author of the report. "In the absence of a cure for the disease, we are really trying to focus on finding better treatment because currently available methods just don't work that efficiently," he says. The body keeps blood sugar - known as glucose - within a narrow range. Extra glucose floating through the bloodstream, which is common after eating a meal, is captured and kept in the liver. When blood glucose runs low, the liver releases its stores back into the bloodstream. When those reserves are tapped out, liver cells turn on genes to make more glucose to fuel the body.

The research team found that GCN5 chemically alters another protein called PGC-1alpha that normally turns on a set of genes to manufacture enzymes required for glucose release. When GCN5 is fully functional in liver cells, this cascade is turned off and glucose is not released from those cells. Removal of functional GCN5 from liver cells restores the cells' ability to release glucose. The researchers showed that GCN5 alters its target, sabotaging it by adding a chemical tag called an acetyl group. By using molecules that glow fluorescently, the researchers saw under high-power microscopes that GCN5 carries its tagged target to a different location in the cell's nucleus - sequestering it away from the genes it's normally meant to turn on. "GCN5 has been generally shown to turn on genes. No one knew that GCN5 could be used to turn off pathways" says Lerin. "It was a bit of a surprise." When the researchers put GCN5 into live mice, they found that it can in fact decrease blood glucose levels. Liver cells in mice that were given no food for 16 hours actively release glucose into the bloodstream. Introducing GCN5 into their livers, however, causes blood glucose levels in these mice to be reduced. "These results show that changing GCN5 is sufficient to control the sugar balance in mice," says Puigserver. "Therefore, GCN5 has the potential to be a target for therapeutic drug design in the future."

The researchers were funded by the Secretaria de Estado de Universidades e Investigacion del Ministerio de Educacion y Ciencia of Spain, the Ellinson Medical Foundation, the American Federation for Aging Research and the American Diabetes Association. Authors on the paper are Lerin, Joseph Rodgers, Dario Kalume, Seung-hee Kim, Akhilesh Pandey, and Puigserver, all of Hopkins.

On the Web: www.hopkinsmedicine.org

DATE: May 26, 2006

More than half of the 185,000 amputations in the U.S. each year are a result of diabetes, a disease that plagues an estimated 20.8 million Americans -- seven percent of the population -- and is on the rise. Diabetic neuropathy, nerve damage that causes a loss of sensation in the hands and feet, can allow small injuries to go unnoticed and become severely infected. Tight control of blood sugar can keep neuropathy at bay, but there is no cure.

"There are a variety of medications that are available now that can help with the pain but unfortunately, there's nothing available to help with numbness or prevention of nerve damage," says diabetes specialist Mark Kipnes, MD, director of the Diabetes and Glandular Disease Research Clinic in San Antonio, Texas.

But now Kipnes is leading the first human testing of a new drug that might prevent or even reverse such damage. Designed by researchers at Sangamo Biosciences, it uses a natural protein that turns on the patient's own gene for helping nerve growth. As the researchers wrote in the journal "Diabetes" tests on diabetic rats showed that repeated treatments with the drug led to increasingly improved nerve function.

Sangamo biochemist Philip Gregory notes that this Phase 1 clinical trial is the first human test of an entirely new class of drug that could turn any gene on or off depending on the disease. "These proteins are natural proteins that exist in essentially every human cell, there are thousands of them, they naturally regulate genes in cells," Gregory explains.

These gene-regulating proteins have an important feature called a zinc finger domain. The zinc finger region, whose structure was discovered by Nobel laureate Aaron Klug, is a finger-shaped structure containing a zinc atom. Unlike most proteins, those with these special domains can actually bind to DNA and act as transcription factors -- telling specific genes to turn on or off.

"So what we're able to do is to engineer these proteins so that they can bind to different genes of our choice," says Gregory. In this case, the gene targeted by the Sangamo team was one encoding a protein called VEGF-A, a natural growth factor.

"In diabetes, patients have significant blood sugar changes that give rise to the production of toxic byproducts in tissues that drive, essentially, a poisoning of the nerves," says Gregory. He explains that because VEGF-A naturally stimulates regeneration of nerves and the blood vessels that nourish them, it can reverse the damage caused by the glucose-driven degeneration.

"It's not that diabetic patients lack the gene for VEGF-A," explains Gregory, "They continue to have the gene and they produce VEGF-A, but it's like the patient's cells don't realize they could be more protected or suffer from the disease much less if the cells produce more of this particular protective factor." Gregory says that this gene therapy is more of an addition strategy -- they're simply adding more of the gene that's already present in the cells.

Gregory says turning on the gene should also have an advantage over strategies that just give patients the VEGF-A protein. "The natural form of VEGF-A is actually a family of factors," he says, and the researcher believe that, "it's that entire set, that entire family of factors that drive the full biological response. So putting in just one piece of the puzzle is not sufficient. You have to provide them all, and this is the most efficient way of doing that."

While patients in the Phase 1 trial tolerated the drug well it needs to be tested for longer time periods to prove its safety -- particularly since this treatment would need repeated administration. As Gregory explains, "Obviously this is a chronic disease and we need to have a chronic treatment, if you like, for such a disease."

Kipnes is excited about the prospect of having a treatment to offer people with diabetic neuropathy, but he points out that there may be some risks. As he points out, injecting a growth factor into body could theoretically encourage other, unwanted things to grow. "So these patients are very carefully screened for any kinds of cancers and tumors," he says.

The researchers report there's been no evidence of carcinogenesis in their animal studies. They also say that some patients in the safety trial showed some anecdotal improvement in their nerve function. Kipnes is currently recruiting patients for a second safety trial as well as a larger Phase 2 trial of the drug's effectiveness. Both are scheduled to begin later this year.

The most recent publications about this new therapy can be found in Diabetes, May 26, 2006, Nature, June 2, 2005, and Nature Biotechnology, June 2005. The research was funded by Sangamo Biosciences Inc.

DATE: May 19, 2006

Biomechanics practitioners understand all too well that diabetes claims a limb every 30 seconds (according to the Nov. 14, 2005 issue of The Lancet). And while there are volumes of research into wound and ulcer healing, clinicians are beginning to understand more about the mechanisms that cause ulcers in the first place. That knowledge may help them design such interventions as casting and footwear more precisely to prevent foot ulcers or help them heal faster. Researchers agree that diabetic patients have increased joint stiffness and reduced joint mobility, especially in the ankle joint. Several studies have found increased plantar loading in diabetic patients, which seems to increase the risk of plantar ulcers.

A study by researchers in the internal medicine department at Tor Vergata University of Rome, published in Diabetic Medicine in December, found that mobility of the first metatarsophalangeal joint was significantly reduced in diabetic patients, both those with and without neuropathy. That study also found the plantar fascia and Achilles tendon were significantly thickened in diabetic patients both with and without neuropathy compared with a control group. The authors theorized that this thickening may contribute to the windlass mechanism, which enables stiffening of the foot during normal gait, beginning early and continuing throughout gait. "We are convinced that thickening of the plantar fascia and Achilles tendon does contribute to early appearance of the windlass mechanism. Consequently, the foot becomes rigid and very poorly adaptable in its interaction with the floor," said Luigi Uccioli, professor of medicine at Tor Vergata and one of the study's coauthors.

A University of Iowa study, to be published in Gait & Posture and available now online, found that greater stiffness of the heel and ankle at rest didn't necessarily mean more stiffness during gait. The Iowa researchers found a reduced passive range of motion at the ankle and increased stiffness at rest among diabetic patients. However, the ankle motion, stiffness, and plantar pressure of the diabetic patients were similar to those of a control group during walking at the same speed. The diabetic patients in the Iowa study were using strategies such as reduced push-off and shortened stride length to compensate for their stiffness at rest, said Smita Rao, a graduate student in the orthopedic gait analysis laboratory at Iowa and the study's lead author. In spite of these strategies, the diabetic patients sustained plantar loads similar to those of the control subjects. This suggests other factors may render diabetic patients vulnerable to increased plantar loading, and these factors may be intrinsic to the foot, Rao said. Rao's paper is part of her dissertation research, which is continuing in a new study of segmental foot mobility in diabetic patients. Her team has found that sagittal motion of the first metatarsal and forefoot and frontal motion of the calcaneus were associated with increased plantar loading under the respective segments in diabetic patients. These findings, still unpublished, may provide more insight into the mechanisms that cause increased plantar loading in diabetic patients.

The Rome study found diabetic patients had increased loading times and force integrals under the metatarsals compared with non-diabetic controls. But the Iowa study found no difference between diabetic and non-diabetic patients. Rao attributes this discrepancy to the fact that the patients in her study wore their customary footwear, whereas the Rome patients were barefoot. Footwear affords a more even distribution of load on the plantar foot and may also facilitate forward transfer of body weight, she said. Another recent study, published in March in Clinical Biomechanics, found peak plantar pressures in the surviving foot among diabetic patients with a transtibial amputation were higher than in diabetic patients without amputation. The researchers found the amputees had shorter strides and a slower gait and walked less per day. They theorized that changes in gait and level of walking activity may affect plantar pressure in the surviving foot and increase the risk of a second amputation.

Reduced plantar loading, reduced risk

All of the above research adds up to one conclusion: The more plantar loads are reduced in diabetic patients, the better their chances for avoiding amputation. In addition to antibiotics and wound healing therapies, Uccioli suggests surgery to lengthen the Achilles tendon as a successful intervention for some ulcers, and Rao cites botulinum toxin injections and silicone implants. But orthotic interventions, including stockings, bracing, footwear, and casts, are also available. Recent research has shown that each of these approaches can be effective. A team of investigators at Twenteborg Hospital in Almelo, the Netherlands compared the offloading effects of four different devices: a custom-molded insole shoe, a fiberglass-cast MABAL shoe (a combination cast and shoe, whose name is an acronym for the inventor and place of invention), a prefabricated pneumatic walking brace, and a bivalved total contact cast. The Twenteborg researchers, who published their findings in the Nov-Dec issue of Wound Repair and Regeneration, found that all four approaches achieved significant reduction in forefoot and heel plantar pressures compared with a control shoe. The total contact cast attained the greatest degree of plantar pressure reduction, followed by the walking brace; the MABAL shoe achieved less reduction, and the insole the least. The authors note that it's unclear how much plantar offloading is necessary to treat diabetic ulcers.

The only drawback of these interventions is that plantar pressures in the midfoot region were increased with all four, leading the researchers to theorize that they transfer loads to the midfoot region. This may be a problem particularly for patients with Charcot foot, said Robert van Deursen, one of the study's coauthors and the director of physiotherapy at the Research Centre for Clinical Kinesiology at Cardiff University, in Wales, U.K. A frequent result of Charcot foot, midfoot collapse increases pressures there, which also increases the risk of ulceration. But for patients without Charcot foot, midfoot plantar pressures are generally low compared to the heel and forefoot, and-even after reduction in forefoot and heel pressures-the increased midfoot pressure isn't as great as in those areas. The bivalved total contact cast does seem to provide the greatest amount of plantar offloading, but some research shows that the TCC reduces patients' activity levels significantly, van Deursen said. Also, the specialized expertise of TCC casting may not be available in some parts of the world. Preventive foot care socks succeeded in reducing plantar foot pressures in patients with diabetic neuropathy in a study published in the August issue of Diabetes Care. Investigators at Withington Hospital in Manchester, U.K., found the socks increased maximum foot contact area by 7.9% and reduced total foot pressure by 9%. Forefoot pressure was reduced 10.2%, with a 14.2% increase in contact area. There's not enough information yet to know how much pressure reduction is needed to prevent diabetic ulcers, according to the study's author, Adam Garrow, a research fellow with the diabetes foot clinic at Withington Hospital. "There is a general consensus that rest and such devices as the total contact cast are the best treatments for plantar foot ulcers," he said.

Another team of Twenteborg researchers tested four forefoot-offloading shoes, plus the MABAL shoe on diabetic neuropathic patients and presented their results at the XXth Congress of the International Society of Biomechanics/29th Annual Meeting of the American Society of Biomechanics, in August. They found the Thanner Cabrio, the Rattenhuber Talus, the Fior & Gentz Hannover, and the Pullman shoe were all equally effective at offloading the forefoot of the diabetic subjects. All four shoes achieved greater reduction than the MABAL shoe, but the Fior & Gentz product was too uncomfortable to be used as a therapeutic shoe. The Twenteborg researchers are studying the effectiveness of this kind of shoe at healing neuropathic plantar forefoot ulcers, according to lead author Sicco Bus, a professor of rehabilitation at the University of Amsterdam. The researchers also plan to study the effects of the forefoot-offloading shoe on the patients' gait in the future, Bus said. Footwear and casting can both be part of a clinical intervention to treat diabetic ulcers, Rao said. "While there is no consensus yet about the most effective footwear, there are exciting new developments in custom footwear design for individuals with diabetes," she said. She cites a study by researchers at the Cleveland Clinic who found that measurements of peak pressure sites and computer modeling could help researchers place custom-fabricated plugs in orthoses to replace a shoe's midsole to reduce plantar pressures more effectively. That study was published in the Journal of Biomechanics in September. "As with any intervention, compliance is critical when it comes to footwear use," Rao said.

By Charlie Kupperman - freelance writer based in San Francisco

DATE: May 12, 2006

A University of Houston professor and his student have made a major discovery in the field of diabetes research and diagnosis, finding a new mechanism for the formation of insulin crystals in the pancreas.

Peter Vekilov, associate professor of chemical engineering, and Dimitra Georgiou, a recent doctoral graduate in chemical engineering, both in UH's Cullen College of Engineering, are behind this breakthrough. Since insufficient insulin production in the pancreas is one of the primary causes of adult-onset diabetes, Vekilov and Georgiou are studying the process of how insulin is produced in the first place. Understanding how the body creates this hormone will make it easier for researchers to discover why some individuals do not produce enough insulin and thus develop diabetes, Vekilov said. Specifically, the two have focused on the creation of insulin crystals, the form in which insulin is stored in the pancreas before it is released in the bloodstream.

"It is possible that the insulin deficiency happens when the crystals don't form properly and then part of the insulin that is produced gets destroyed," Vekilov said. Proinsulin, a molecular precursor to insulin itself, is the reason for these crystals. After an insulin molecule is produced from proinsulin, it attaches to an insulin crystal only in special locations where other insulin molecules have formed right angles, called kinks. Using atomic-force microscopy, they discovered a new mechanism by which insulin molecules attach themselves to crystals to form these kinks. They found that groups of insulin blocks create large protrusions, dubbed "mounds" by Vekilov and Georgiou. The very nature of these mounds results in the creation of multiple kinks - far more, in fact, than other methods of kink formation.

By providing so many spaces where insulin molecules can attach to an insulin crystal, these mounds allow for the rapid growth of that crystal and only form when there is a surplus of insulin that allows for rapid crystal growth. Since no mounds appear when there is a lack of insulin and insulin crystals both grow and dissolve at kinks, mounds are important sources of a crystal's net growth.

"Typically in nature, fast growth also results in fast dissolution," Vekilov said. "But this process cheats physics because when there isn't a lot of insulin, mounds don't form. It's an asymmetric mechanism that has no balance."

While this discovery will play a significant role in gaining a better understanding of diabetes, it also is an historic find in the area of crystal formation and use, as only the third mechanism of crystal formation ever discovered. Before this finding, there were only two known ways that crystals grew; the first was proposed in 1876 and the second in 1968. Though the first and second discoveries, proposed by prominent American scientist and founder of modern thermodynamics J.W. Gibbs and by Russian scientist V.V. Voronkov, respectively, only recently demonstrated their applicability to real systems, this latest mechanism has already been experimentally proven in the work by Vekilov and Georgiou.

"It is possible that crystals composed of materials other than insulin also grow in this manner," Vekilov said. "If so, this discovery could significantly impact any number of fields that deal with crystals. It can help us understand all processes of crystal formation, including semiconductor and optical materials, geological crystallization, ice formation and the physiological and pathological crystallization of proteins and small molecules."

The University of Houston, Texas' premier metropolitan research and teaching institution, is home to more than 40 research centers and institutes and sponsors more than 300 partnerships with corporate, civic and governmental entities. UH, the most diverse research university in the country, stands at the forefront of education, research and service with more than 35,000 students.

DATE: May 05, 2006

Nearly 2.8 million teenagers in the United States could be on the brink of developing Type 2 diabetes — a disease that used to be almost exclusive to adults — and another 39,000 teens might already have the disease, a University of Washington scientist has estimated in a new analysis of the growing prevalence of diabetes. The findings support growing concerns among public-health authorities nationwide over the increasing number of kids who are overweight, a major factor in the development of Type 2 diabetes. The disease can eventually lead to kidney failure, limb amputations, blindness, heart disease, strokes and high blood pressure.

“What we’re seeing is a reduction in physical activity and an increase in the prevalence of overweight kids,” said Glen Duncan, the University of Washington assistant professor of nutrition who conducted the study. “These things go hand in hand with diabetes, so this (the findings) is no surprise to me at all.”

About 18.2 million people in the United States have diabetes, including 210,000 people younger than age 20, according to the Centers for Disease Control and Prevention. Another 1.3 million new cases a year are being diagnosed, and the vast majority are Type 2, the agency said. The disease formerly was almost exclusive to people older than 40.

Patients with Type 2 diabetes are not able to use the insulin made by their bodies to metabolize glucose in the body. Those with Type 1, formerly called juvenile diabetes, are not able to make insulin; more than 1 million Americans have that form of the disease.

Duncan’s research, reported in the May edition of Archives of Pediatrics & Adolescent Medicine, echoes previous findings from the National Institutes of Health that showed a growth of Type 2 diabetes in younger people. Duncan used data from extensive national health and nutrition surveys from 1999 to 2002 to reach his findings. Among a sample of 4,370 youths aged 12 to 19, only 18 had been told by a physician they had any type of diabetes. But blood samples from 1,496 who said they didn’t have the disease showed that about 11 percent had impaired glucose tolerance levels, or were “pre-diabetic.”

The findings indicated that 39,000 U.S. teens have Type 2 diabetes and nearly 2.8 million are pre-diabetic. For adults, weight loss and exercise have been shown to prevent pre-diabetes from progressing to full diabetes. Physicians believe that’s true for young people as well, and family physicians and health officials nationwide have been sounding alarms about keeping young people trim.

DATE: April 28, 2006

Clinical trials now under way are testing a once-radical theory: The cause of Alzheimer’s disease is linked to diabetes. The trials are looking at whether the diabetes drug Avandia can slow or stop the relentless progression of Alzheimer's disease. Preliminary trials suggest that it can -- at least in patients who do not carry the ApoE4 gene linked to earlier and faster-progressing Alzheimer's disease. That's good news as well as bad news. New ways to treat and prevent Alzheimer's disease are sorely needed. On the other hand, the theory behind the treatment predicts that the same processes that underlie diabetes also underlie Alzheimer's disease.

The current U.S.diabetes epidemic is linked to the ongoing obesity epidemic. Does rising obesity also predict an upsurge in Alzheimer’s disease? “That is perfectly consistent with our theory," Allen D. Roses, MD, tells WebMD. "A number of researchers find similarities between the metabolism of diabetes and the metabolism of Alzheimer's disease. And the pancreatic beta cells lost in diabetes come from same lineage as brain neurons." People with diabetes are at increased risk of Alzheimer's disease, says Bill Theis, PhD, vice president for medical and scientific affairs at the Chicago-based Alzheimer's Association. And at least in women, Theis says, being overweight or obese also raises a person's risk of Alzheimer's. "We have studies that say people who are heavy at middle age end up with a higher risk of Alzheimer's disease," Theis tells WebMD. "It is a little confounded, because if you are male and very heavy you don't tend to get old enough to get Alzheimer's disease -- but the trend is clear in women."

Roses, now senior vice president for genetics research at GlaxoSmithKline, and Ann M. Saunders, PhD -- his research partner and wife -- describe the theory in detail in the April 2006 issue of Alzheimer's & Dementia: The Journal of the Alzheimer's Association. Roses isn't the only Alzheimer's researcher to back this controversial theory. But he's among the most distinguished. In the early 1990s, Roses and colleagues were the first to link the ApoE4 gene to early-onset Alzheimer's disease. "We discovered that the ApoE gene is significantly associated with the common form of Alzheimer's disease," Roses says. "What wasn't known is how it was operating in the brain. Over several years, we were doing experiments to see what the different forms of ApoE -- ApoE4, ApoE3, and ApoE2 -- were doing to metabolism in animals. We found a change in sugar utilization."

The body has intricate, interconnected systems for controlling how its main fuel -- sugar -- is burned. In diabetes, the system is terribly out of whack. It's also out of whack in Alzheimer's disease, Roses says. He points to imaging studies showing that the brains of people who carry the ApoE4 gene have a lowered sugar-burning "thermostat."

"What we have here is abnormal [sugar] metabolism in people well before they get plaques and tangles, and [brain] scans showing decreased glucose metabolism -- all the way down to age 18, the earliest age we can do this kind of scan -- in ApoE4 people," Roses says. "And we also have mapped out, in cases of Alzheimer's disease, amyloid plaques in the areas were there is abnormal [sugar] metabolism."

The company for which Roses works -- GlaxoSmithKline -- makes Avandia, one member of a class of diabetes drugs that improves the use of sugar by cells. Small clinical trials show that Avandia slightly improved mental function in patients with mild-to-moderate Alzheimer's disease. But it only seems to work in patients who don't carry the ApoE4 gene. GlaxoSmithKline is a WebMD sponsor. "So if you are suffering Alzheimer's disease and don't have ApoE4, your results seem to get better faster with Avandia," Roses says. "But if you have ApoE4, it may not work at all, or you may need a higher dose."

Roses says the FDA has already approved a large-scale clinical trial of Avandia in genetically screened patients with Alzheimer's disease. Until the results of this trial are known -- and the results are years away -- Roses strongly warns people not to try using Avandia as an Alzheimer's treatment. Theis, too, says it's far too early to try Avandia or any other diabetes drug for Alzheimer's disease. "There's a list of things available to treat other diseases with promise for Alzheimer's disease," he says. "But you would be very foolish to take any of these medicines with the hope it would alleviate Alzheimer's disease." Yet the new findings give Theis hope. "Here is another door we are opening that possibly opens on the next generation of treatments for Alzheimer's disease," he says. "And the more doors we open, the closer we are to finding the one with the prize behind it."

DATE: April 21, 2006

Medtronic announced FDA approval of the MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System, a progressive new therapy available for patients who use insulin to treat diabetes.The company said the insulin pump integrates with REAL-Time continuous glucose monitoring (CGM). The new technology will help patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications, including coma, blindness, kidney failure, amputation, impotence, and heart disease.

The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring (CGM) System, and a MiniMed Paradigm insulin pump. The REAL-Time CGM System, the company noted, relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays to 288 readings a day - nearly 100 times more information than three daily fingersticks. REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick. The REAL-Time CGM System component is indicated for any patient 18 years of age or older, and insulin pump therapy for all patients requiring insulin.

"The approval of the MiniMed Paradigm REAL-Time System opens the door to the next generation of diabetes management," said Robert Guezuraga, president, Medtronic Diabetes. "As this is the first integrated insulin pump and continuous glucose monitoring system ever approved, we feel this new therapy will revolutionize the way patients manage their diabetes and will improve their lives."

More information available at www.minimed.com

DATE: April 14, 2006

Mayo Clinic researchers are sounding an alert about side effects of shock wave lithotripsy: in a research study, they found this common treatment for kidney stones to significantly increase the risk for diabetes and hypertension later in life. Risk for diabetes was related to the intensity of the treatment and quantity of the shock waves administered; hypertension was related to treatment of stones in both kidneys.

Shock wave lithotripsy uses shock waves to break up an impassable kidney stone into smaller, sandlike pieces which can be passed spontaneously, usually within a month. The patient and the lithotriptor that emits the shock waves are placed in a water bath. Water allows easier conduction of the shock waves through the patient's tissue and precise focus on the kidney stone.

"This is a completely new finding," says Amy Krambeck, M.D., Mayo Clinic urology resident and lead study investigator. "This opens the eyes of the world of urology to the fact that hypertension and diabetes are potential side effects. We can't say with 100 percent certainty that the shock wave treatment for the kidney stones caused diabetes and hypertension, but the association was very strong. The risk of developing diabetes after shock wave lithotripsy is almost four times the risk of people with kidney stones treated with medicine, and the risk of developing hypertension is one and one-half times, which is a significant risk increase."

The study, which is the first examination of the effects of shock wave lithotripsy over the long term, involved reviewing charts of 630 patients treated with shock wave lithotripsy in 1985 at Mayo Clinic. The researchers sent those still alive a questionnaire; almost 60 percent responded. The researchers matched the patients treated with lithotripsy to patients similar in age, gender and initial time of seeing a urologist for kidney stones who received a different treatment, medicine. Nineteen years post-treatment, those treated with lithotripsy had 3.75 times the risk of having diabetes as those given the other kidney stone treatment. The degree of increased risk rose with greater number and intensity of shocks administered. Those treated with lithotripsy also had 1.47 times the risk of having hypertension -- high blood pressure -- than those who received the other kidney stone treatment; risk was highest for those who had both kidneys treated.

The researchers hypothesize that the increase in risk for diabetes associated with shock wave therapy for kidney stones relates to damage inflicted to the pancreas, a previously known risk of lithotripsy, which may affect the islet cells in the pancreas that make insulin. They believe the increased risk for hypertension may relate to scarring, which the treatment may cause to the kidneys and could alter the secretion of hormones centered in the kidneys like renin, which influence blood pressure.

Drs. Krambeck and Joseph Segura, M.D., Mayo Clinic urologist and study investigator, say that they continue to use shock wave treatment, among other alternative treatments for kidney stones.

"Despite the risks, shock wave therapy still can save the day for patients, and it would be a mistake to put it on the shelf," says Dr. Segura.

The researchers indicate that they now counsel patients about the potential risk for diabetes and hypertension prior to shock wave treatment.

Dr. Segura stresses the need for kidney stone patients and their physicians to weigh the pros and cons of shock wave treatment according to individual situations. "It's a trade-off about whether the risks are worth taking," he says. "We're assuming doing nothing is not the right thing to do for patients. You have to look at it in terms of treatment alternatives -- percutaneous stone removal [removing a kidney stone through a small incision in the patient's back using an instrument called a nephroscope] or ureteroscopy [snaring a stone with a small instrument passed into the ureter through the bladder and then breaking up the stone with ultrasound or laser energy] -- each of which has its own set of risks."

The Mayo Clinic researchers examined the long-term effects of lithotripsy for patients treated with a 1985 lithotriptor, one of the early models, in this study. Drs. Krambeck and Segura say additional research studies, including research on newer machines and different models, are needed on shock wave therapy and risk for diabetes and hypertension later in life.

Prior to age 70, approximately 10 percent of men and 5 percent of women will experience a kidney stone, according to the National Institutes of Health. About 1 million people in the United States have had shock wave lithotripsy, says Dr. Segura.

To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org

DATE: April 07, 2006

Doctors in Ireland are among the first in Europe to use electrical implants to treat a common but disabling stomach condition. Two patients with type 1 diabetes have benefited from the groundbreaking procedure at Cork University Hospital. The condition, called gastroparesis, occurs when the stomach takes too long to empty its contents, causing heartburn, nausea, vomiting, erratic blood sugar, and acid reflux. Almost half of all diabetics will suffer from the condition because high blood sugar damages the Vagus nerve which controls movement of food through the digestive tract.

The first two patients to have the treatment in Ireland were a 23-year-old man who has had type 1 diabetes for 16 years, and a 60-year-old woman, who had been repeatedly admitted to hospital with severe gastroparesis linked to type 1 diabetes over the last two years. The results show that after six months, both patients had a significant improvement, with a marked reduction in nausea and vomiting. 'These are the first two patients in Ireland to have gastric stimulators implanted, and we are very pleased with the results," says Dr Vikrant Sibartie, senior registrar at Cork University Hospital. "Our results show a big reduction in symptoms and improvement in quality of life. These were patients who had been constantly admitted to hospital and who had not responded to other treatments. Treating this condition is a major challenge for doctors, especially when symptoms are persistent and severe and do not respond to drugs. This treatment offers a great deal of hope to people in that position." In the surgery, two electrodes were implanted in the wall of the stomach on each of the patients and attached to a battery and control pack implanted under the skin of the abdomen. Natural electrical signals are involved in the working of the stomach, and the theory behind the treatment is that the stimulation from the electrodes will help to restore normal working of the Vagus nerve.

DATE: March 31, 2006

Men who sleep too much or too little are at an increased risk of developing Type 2 diabetes, according to a study by the New England Research Institutes in collaboration with Yale School of Medicine researchers.

The data published in the March issue of Diabetes Care were obtained from 1,709 men, 40 to 70 years old. The men were enrolled in the Massachusetts Male Aging Study and were followed for 15 years with home visits, a health questionnaire and blood samples.

Six to eight hours of sleep was found to be most healthy. In contrast, men who reported they slept between five and six hours per night were twice as likely to develop diabetes and men who slept more than eight hours per night were three times as likely to develop diabetes, according to the lead author, H. Klar Yaggi, M.D., professor in Yale's Department of Internal Medicine, pulmonary section. Previous data from the Nurses Health Study have shown similar results in women.

"These elevated risks remained after adjustment for age, hypertension, smoking status, self-rated health status and education," Yaggi said.

He said researchers are just beginning to recognize the hormonal and metabolic implications of too little sleep. Among the documented effects, Yaggi said, are striking alterations in metabolic and endocrine function including decreased carbohydrate tolerance, insulin resistance, and lower levels of the hormone leptin leading to obesity The mechanisms by which long sleep duration increase diabetes risk requires further investigation.

"There is a lot of interest in determining whether sleep disturbances such as a reduced amount of sleep or disorders like sleep apnea may actually worsen the metabolic syndrome," said Yaggi. Metabolic syndrome is a cluster of risk factors including high blood pressure, obesity, high cholesterol and insulin resistance which increase the risk for heart disease and stroke.

Co-authors include Andre Araujo and John McKinlay. The research was supported in part by the National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Disorders, the Yale Mentored Clinical Research Scholars Program from the National Center for Research Resources, and a career development award from the Veterans Affairs Health Services and Research and Development Service.

DATE: March 24, 2006

Americans are getting fatter and sicker, and that's raising medical costs for employers and employees. A conference at Duke University on Wednesday assembled physicians, economists and experts in health, nutrition and insurance from across the country to explore ways to reduce obesity and diabetes, one of the costly chronic diseases it causes. Annual health insurance premiums have increased more than 30 percent in the past five years, said Robert Ingram, vice chairman of GlaxoSmithKline and a keynote speaker at the conference. "This is not sustainable, not for employers and not for employees," Ingram said. GSK, which has one of its twin U.S. headquarters in the Triangle, develops diabetes drugs, including Avandia. Instead of shifting costs to employees, employers should shift attention to prevention, he said. "Disease is the enemy, not health-care spending."

Employers are beginning to realize that. Take General Motors, for example. The auto maker, which provides health-care benefits to about 1 million employees and their dependents, will introduce at its plant in Flint, Mich., a diabetes care program first adopted by the city of Asheville, said Dr. Joel Bender, corporate director of GM's health services. The program focuses on taking medication properly. Within five years, Asheville's annual medical costs per diabetic city employee decreased about $2,500, or 35 percent. The number of sick days a diabetic employee took was cut in half to about six per year. Other companies offer free, on-site fitness centers that stay open around the clock. Others pay for annual physicals or try to encourage their employees to healthful eating habits. For example, SAS Institute, a software developer in Cary, pays for employees' lunches as long as they choose a nutritious choice in the company's cafeteria. Tools for healthful living are about to become a recruitment tools, said Patricia Cooper, a health-care consultant who also spoke on one of the conference's panels. "It's the next corporate thing," she said. Companies that promote a culture of health are becoming "a cool place to work."

DATE: March 17, 2006

Dubai Saudi Arabia -: Preliminary findings of a study suggests some wisdom lies behind every mother's caution for her child to chew and eat slowly; it may help delay the start of diabetes. A study, conducted by Dr Aus Al Zaid, diabetes consultant at Saudi Arabia's Riyadh Armed Forces Hospital, found that the faster people ate, the higher their risk of developing diabetes. Dr Al Zaid told Gulf News that he wanted to determine if the high prevalence of diabetes in the Gulf was related to the Arab culture of finishing large meals quickly. "As a people, we tend to eat fast. I wondered if that is why diabetes is high here," he said after presenting a lecture at the Arab World Diabetes Summit. The study had 23 men per group consume the same dish at different speeds one in 10 minutes, while the other in 20 minutes. Both groups later switched to determine the reliability of the findings. Both times, the blood sugar level in fast eaters was 30 per cent higher than the slow eaters. Dr. Al Zaid said the findings suggest that over the long term, the pancreas might shut down after continuously producing insulin, leading to diabetes.

DATE: March 10, 2006

Researchers are closer to learning the root cause of insulin resistance, which is what leads to diabetes, by studying the healthy children of those with diabetes.

Monty Littlejohn, a 28-year-old medical student at SUNY Buffalo, is young, fit, and active. But because both of his grandmothers have diabetes, the family history of the disease has him concerned. Diabetes is usually associated with obesity, aging and lack of exercise, but as a medical student Littlejohn knows that diabetes also has a strong genetic component. "It is a little bit scary to think that no matter what I do, this is sort of looming over me in my future," he reflects.

Now researchers hope that studying the exceptions to the rule can provide insight into the underlying biological mechanisms of the disease. Physiologist Gerald Schulman and his colleagues at Yale University studied 20-year-olds whose parents are diabetic. Despite being young, healthy and lean, all of the test subjects had high levels of insulin resistance. Insulin resistance is often referred to as "pre-diabetes" because it's the first sign that the body is not processing sugar properly.

After eating a meal, the digestive system breaks most food down into units of glucose, a simple sugar that is one of the basic energy sources for the body. Insulin is a hormone made by the pancreas, which triggers cells to absorb the glucose and use it. Once inside the cell, small energy factories called mitochondria convert the glucose sugar into a chemical called ATP. ATP powers every cellular and bodily function, from thinking to moving. When someone is insulin resistant, his or her cells aren't able to absorb sugar from the bloodstream to make ATP, which leaves the cells starving for energy even though it's right there just outside the cell wall. Another thing that these young patients with family histories of diabetes had in common is that despite being lean, they actually had more fat inside their cells. And as Shulman says, "Fat inside the muscle cell causes insulin resistance; so the real question becomes, 'Why is the fat building up?'"

One of the goals of the team's research was to figure out exactly what was happening on a cellular level to cause this fat buildup. Shulman says there were two possible explanations, "So it became a question of, are there defects in the fat cells in the body, releasing more fat to liver and muscle, causing the buildup? Or are there defects in the mitochondria… the factories in all the cells of our body that produce energy?" His group designed several experiments that used a technology called Nuclear Magnetic Resonance (NMR) spectroscopy to actually measure different things inside the volunteers' cells. One kind of NMR allowed them to directly measure the amount of fat both inside and outside the muscle cells. They also developed two other kinds of NMR spectroscopy — one to measure the activity of the mitochondria inside the cells and another to quantify how quickly the mitochondria were making ATP. "So we use all three NMR tools here to get an integrated picture of metabolism in human skeletal muscle," Shulman explains. They found that compared to normal volunteers, the insulin-resistant group had much less mitochondrial activity. So it was, in fact, the mitochondria that were to blame for the fat building up inside the cells and not a defect in fat cells.

Shulman says that discovering that reduced mitochondrial activity is to blame is a key step in coming up with treatments and prevention. "I'm very excited about this because, really, if you understand the mechanisms to the disease, this will allow us to develop pharmacologic interventions to correct the disease or ideally prevent it," he says. In an even more recent study published in the Journal of Clinical Investigation, Shulman's team revealed that the lower mitochondrial activity in these insulin-resistant patients is actually due to the fact that they have fewer mitochondria. As a result, the team is also focusing on identifying the genes that might be responsible for this reduced mitochondria count. Until treatments are available, though, Shulman says there's a lot we can do to keep the risk of diabetes at bay. In another study, his team actually observed a total reversal of insulin resistance as a consequence of — you guessed it — regular exercise. "We've taken the same group of individuals and had them exercise four times a week on a stairmaster, and have totally reversed the insulin resistance in skeletal muscle," he says.

Monty Littlejohn is doing his best to take this advice to heart by eating a healthy diet and exercising almost daily. Shulman's recommendation is that we all do the same, "Try to watch [your] weight, stay lean, and more importantly, stay active." Shulman's work was funded by the National Institutes of Health, the American Diabetes Association, the United States Public Health Service, and the Yamanouchi USA Foundation.

DATE: March 03, 2006

Tiny seaweed "bubbles" may be about to revolutionize treatment for Type 1 Diabetes. Sydney Australian nurse Janice Stewart this week became the first Australian in the trial of a new therapy where doctors injected her with pancreatic cells, encased in capsules made from a brown seaweed product called alginate. If all goes as planned, lead researcher Bernie Tuch, of the University of NSW, hopes the simple transplant procedure will mean the end to daily insulin injections for diabetic patients. Initially, Professor Tuch said the hope was that Ms Stewart would be able to reduce her daily insulin intake. That would be an advance in itself for the 51-year-old from Cromer, on Sydney's northern beaches, who has required four insulin injections a day for the past 40 years along with a strict diet and exercise regimen.

Ms Stewart is believed to be just the third patient in the world, behind two Italians, to have the procedure which involves doctors injecting around 200,000 insulin-producing cells, called islets, from a dead donor into her abdomen. Prof Tuch, the Prince of Wales Hospital's diabetes transplant unit director, said the two Italians had been able to cut their daily insulin requirements and he expected a similar outcome for Ms Stewart. "These are mature adult cells and you would expect that they would produce some insulin," he said. "I don't anticipate the patient will come off insulin. I'd like to be proven wrong. "We'll play the cautious game and suggest she'll get some function." Prof Tuch said animal studies had shown five months after the procedure, the viability of the transplanted cells remained high at between 70 and 80 per cent. The key to the experimental transplant procedure is the tiny alginate capsules, about 0.3mm in diameter, which protect the islets from being destroyed by the body's immune system. "These capsules have pores, or little holes on their surface, small enough to block immune cells getting in to destroy the islets ... but large enough to allow the entry of nutrients such as oxygen, glucose and so forth," Prof Tuch explained in an interview. He described the process of getting the islets inside the capsules, as something like blowing bubbles. "You take the alginate, the cells and air," Prof Tuch explained. "You blow the air, the alginate and the cells together and what you get is like blowing soap bubbles." The alginate capsules overcome the need for patients to take immuno-suppressive drugs to prevent the body rejecting the cells. Side effects of such drugs can include infection and cancer.

Ms Stewart, who was sent home from hospital within hours of the procedure, said she had never contemplated a traditional transplant because the drugs were often "worse than the disease". "That really wasn't a consideration," she said. The grandmother of three is the first of six patients in a pilot Australian trial of the transplant procedure expected to take several years to complete. Even if the trial proves highly successful, Prof Tuch said that last year only 204 Australians donated their organs compared to the nation's population of 130,000 type 1 diabetes patients, making supply a big issue. He said patients may also need two or three transplants to achieve the ultimate goal of coming off their insulin altogether. Nevertheless, with further research, doctors may be able to eventually replace the donor cells with insulin-producing stem cells or possibly even pancreatic pig cells. "Time will tell," Prof Tuch said during Donor Awareness Week. He said animal testing was ongoing to determine whether transplanting the cells in another area of the body, such as the spleen, produced a better result. Injections into the pancreas, which is one per cent islet cells, is considered too risky because of the enzymes it also contains to help food digestion. "Those enzymes potentially could ingest anything you inject," Prof Tuch said. "You don't want to take that risk and we know from animal studies that you can inject cells into the peritoneal cavity, the abdomen, and they do work and they will function appropriately. "However, we don't know whether this is the best site so we're exploring other sites. "We're looking at the possibility of putting them in the spleen which has a higher oxygen level and we're doing those animal experiments at the moment. We need to optimize. Higher levels of oxygen is one way to achieve that." Prof Tuch conceded holes in the alginate capsules may not be small enough to prevent cytokines, cells which can be involved in allergic inflammation, from getting in. Although he did not expect a major inflammatory response, because this was not seen in animal studies, Prof Tuch said as a precaution, Ms Stewart had been prescribed a mild anti inflammatory drug. He said if the cytokines did penetrate the capsules and destroyed the islets, Ms Stewart would be back where she started from. Doctors should know whether the procedure had invoked an inflammatory process within weeks. Ms Stewart, who was awake when the procedure was performed under a local anesthetic at the Prince of Wales in Sydney, said she felt a "little bit of pressure" as the transplant was being performed but otherwise no pain. "It really is such a minor procedure," she said. "It would not turn anyone off. It doesn't feel as if anything's happened except I know it has." Ms Stewart said she felt privileged to be the first Australian to have the procedure. "I think what it's going to do is give everybody a bit of hope. It's a start," she said. Only time will tell whether the transplant has been life changing.

DATE: February 24, 2006

An alarming rise in the number of babies and small children with the harshest form of diabetes may be linked to the widespread use of baby wipes, according to researchers in Ireland. Though there is no firm evidence on what has caused the increase, experts believe the wipes may reduce the amount of minor bugs that help the immune system develop in babies. The Diabetes Federation of Ireland has said the number of children suffering from Type One diabetes - which leaves victims dependent on insulin - has more than doubled over the last 20 years. Researchers are carrying out studies on environmental factors as diverse as cleansing agents and breast feeding methods, to try and find the cause for the rise.

In the 1980s, around one in every 1,200 children developed Type One diabetes, but this has grown to one in 500, according to Anna Clarke, a health promotion officer of the Diabetes Federation of Ireland. People with Type One diabetes are usually unable to produce any insulin, and blood-sugar levels must be kept as close to normal as possible through injections, regular exercise and close control of the diet. Ms Clarke said a large number of children under five were being diagnosed with Type One diabetes.

Recent figures showed that in 2001, there were 120 children attending Cork University Hospital for diabetes care. In January 2006, this figure had risen to 207, with complaints that there are not enough resources available to deal with the problem. "There is a lot of under fives getting diagnosed with Type One diabetes, and that means they are under pediatric services for much longer, and obviously they will need medical care for the rest of their lives," she said. She further commented that some researchers believe the rise may be caused by cleansing agents, such as wipes, which have resulted in the reduction in the amount of minor bugs that help develop immune systems. "There is no confirmed proof of it, but they are areas which are being researched. There is a lot of scientific research going on in that area to see if this is the cause for it," she said.

© The Sunday Independent

DATE: February 17, 2006

A research team led by the Donald Danforth Plant Science Center has discovered that green tea could provide a potential new therapy for a rare and often fatal insulin disorder. As published recently in the Journal of Biological Chemistry, Dr. Thomas Smith, Principal Investigator at the Donald Danforth Plant Science Center, Dr. Charles Stanley of The Children's Hospital of Philadelphia and Dr. Franz Matschinsky of the Department of Biochemistry and Diabetes Center, University of Pennsylvania School of Medicine, has determined that epigallocatechin gallate (EGCG) and epicatechin gallate (ECG), two polyphenols found in green tea, can play a significant role in modulating human insulin production. The team determined that the polyphenols are responsible for regulating the production of the enzyme glutamate dehydrogenase (GDH).

"The release of insulin from the pancreas is similar to an automobile manufacturing plant in which specific parts and processes are needed at the right time and in the proper amounts to assemble a complete car. In people producing too little or too much insulin, the pancreas does not contain all the right parts to produce the right amounts of insulin. We've found that green tea polyphenols impact sections of this insulin-production line," Dr. Smith explained. "Previous research conducted by Dr. Stanley on hyperinsulin/hyperammonemia (HI/HA) syndrome has shown that GDH plays a regulatory role in the process of insulin secretion by pancreatic beta-cells," said Dr. Smith. "Children born with this disease have lost the ability to turn off this enzyme. In most children, this often leads to low blood sugar, coma, and eventually death. Our new research supports the hypothesis that GDH plays a role in insulin regulation and demonstrates that these safe and non-toxic compounds found in green tea can help to turn off this uncontrollable enzyme and may eventually lead to a new family of therapeutics," Dr. Smith explained.

"Dr. Smith's research is an example of how research can lead in unanticipated directions; in this case, Dr. Smith identified a chemical in plant leaves that can impact a human condition. While the results were not anticipated, they are logical and, now, can be explained by experimental results. Such discoveries are the tip of the iceberg that awaits as plant biologists work together with scientists in other disciplines to identify areas of common interest and potential applications," explained Danforth Center President, Dr. Roger N. Beachy. "The first phase of plant science focused on disease resistance to increase yields; the next phase of research is focused on developing new plant varieties that will contain enhanced nutritional and other compounds that will improve human health and address chronic diseases such as diabetes. "The research partnership that led to these findings was created by coincidence in 1998 when Dr. Smith published the first structure of mammalian GDH and Dr. Stanley announced that GDH plays a regulatory role in insulin secretion. When the researchers read each other's papers, they began their collaboration.

Founded in 1998, the Donald Danforth Plant Science Center is a not-for-profit research institute with a global vision to improve the human condition. Research at the Danforth Center will enhance the nutritional content of plants to improve human health, increase agricultural production to create a sustainable food supply, and build scientific capacity to generate economic growth in the St. Louis region and throughout Missouri. Visit www.danforthcenter.org for additional information.

DATE: February 10, 2006

When Robert Cleveland was a boy, in place of a birthday cake his mother wrapped an oatmeal box in colored paper and put candles on top. ''I never had any sweets as a child,'' he said. ''Never.'' Since he was 5, he has lived within the strict boundaries imposed by diabetes, knowing that if he loosened his grip on the disease it would ravage his body -- the terrifying complications, the shortened life span. For years, the only diabetic he knew was the principal of his grammar school, who lost one leg to the disease, and then the other, ''and I remember wondering how long it would be before I lost mine.''

Then his big brother, Gerald, got diabetes at age 16 and also adopted a set of meticulous lifelong habits. He scribbles sugar readings and insulin doses in a logbook, tests the level of sugar in his system seven or eight times a day, avoids desserts and simple starches, exercises and has always stayed reed-thin. ''Even so, I never expected to live to be 50,'' he said. Both brothers have done a bit better than that: Gerald turned 90 this month, and Robert will be 86 in March, and they are in fairly good health for their ages. Experts say that they know of no other childhood diabetic who has lived to be as old as Gerald, and no one who has survived with the disease as long as Robert has -- almost 81 years. ''My main reason to stay alive,'' Gerald said, ''is to prove to young people there's a way to live with diabetes, to live well.''

As diabetes poses a rapidly rising threat to Americans' health, the lives of these brothers from Syracuse offer the ultimate diabetic success story, with telling insights into what is possible, and at what cost. The Clevelands have lived long and healthy lives in part through extraordinary discipline in diet and exercise, but they have also suffered medical complications and harrowing close calls. Scientists who have tracked the brothers and other long-term diabetes survivors say that while they almost certainly have some genetic advantages, what sets them apart just as clearly are vigilance, hard work, self-sacrifice and determination. ''They're a little bit obsessive about their records and their diets,'' said Dr. George L. King, research director of the Joslin Diabetes Center in Boston and a professor at Harvard Medical School. He heads a study of people who have lived with diabetes for at least 50 years -- more than 400 of them, so far. They arrive at the center, he said, carrying ''years and years of records, sometimes decades,'' showing medical tests, blood sugar readings, insulin doses, exercise, even daily food consumption. ''Most of them do quite a bit of exercise, they are more careful about their health than even most diabetics, and they also have a very positive outlook.'' Nearly all of these patients have Type 1 diabetes, also known as juvenile diabetes, which usually develops in childhood. But the lessons learned from them also apply to Type 2 diabetes, a much more common ailment that usually begins in adulthood and is closely associated with obesity, poor diet and lack of exercise. As Americans grow heavier and more sedentary, Type 2 has become the nation's fastest-growing major disease.

Controlling diabetes still demands a rigorous set of daily tasks and choices, but they have become vastly easier in the last few decades, and millions of people manage them well. But millions of others do not, greatly increasing their risk of crippling complications and early death.Even when the Clevelands were small, doctors understood that a rigidly controlled diet and regular exercise could stabilize blood sugar and reduce the amount of insulin needed. Many people had neither the means nor the mind-set to follow such instructions, but the Clevelands' mother, Henrietta, did, and she taught her boys well. ''The doctor prescribed the diet I should be on, and my mother was most careful about sticking to it,'' Robert Cleveland said. ''There were very few carbohydrates, a quart and a half of milk every day, and there were lots of vegetables and proteins. She weighed everything I ate on a scale. I could have 20 grams of bread at breakfast, which meant I couldn't have a complete slice.'' Gerald calls himself a compulsive reader of food ingredient labels, appalled at both the contents of packaged foods and the ignorance of consumers. ''I get so frustrated with some people, even some people with diabetes,'' he said. ''They don't look at the labels, they don't know what a carbohydrate is or even really what a sugar is, and they don't understand how the body uses food. You have to understand these things.'' Gerald recalls that for his parents, his two brothers, his sister and him, ''life revolved around Bob and his diabetes, and all the work that was involved, and the fear and the need to watch out for him.'' What makes the longevity of the Clevelands and some other diabetics all the more remarkable is that they lived most of their lives in the dark ages of diabetes care. When they were young, the disease was expected to lop 20 years off their lives. There was none of the modern gadgetry for measuring and controlling it, and the reasonable expectations for diabetics were amputations, blindness, kidney failure and heart disease.

Yet against immense odds, the Clevelands endured, even thrived, living to have careers, long marriages, children, grandchildren and great-grandchildren. ''To live as long as the Cleveland brothers, through those times when things were so much worse than they are now, is incredible,'' said Aaron J. Kowalski, scientific program manager at the Juvenile Diabetes Research Foundation. ''Yes, it's genetics, but it's discipline, too. It shows what you can do.'' The Clevelands arrived at the right time in history, but barely. When they were born, Type 1 diabetes was still a death sentence -- within weeks or months in most cases, or in a few years on what amounted to a starvation diet. Type 2 could often be controlled with diet and exercise, but otherwise, it usually led to years of debilitating illness and a shortened life. Then, in 1922, scientists at the University of Toronto isolated insulin in a form that was effective and safe enough for human use. Suddenly, thousands of people were delivered from the brink of death, but the lives ahead of them were hard. Controlling diabetes was hard and painful work in the early decades, and what would be considered good control today was simply out of reach. Disposable sterile syringes with fine-gauge needles did not exist; diabetics injected themselves with glass syringes and thick steel needles, reused again and again, and boiled each time to kill germs. Many people developed infections and abscesses from imperfectly sterilized syringes. ''I remember my mother sharpening the needle each time on a whetstone,'' Robert Cleveland recalled. ''But sometimes it was like getting stuck with a knitting needle.''

In the early years, the insulin, which was made from ground-up pancreases of pigs and cows, was so loaded with impurities that the doses needed were several times as large as those used today -- and the bigger the dose, the more it hurt. The strength of the insulin was also inconsistent at first. Even after a few years, when the product became purer and more predictable, some people suffered serious adverse reactions to it. Diabetics suffered a roller-coaster effect of blood sugar highs and dangerous lows. Until the development years later of long-acting insulins that allowed more stability, doctors advised patients to interrupt their sleep to inject themselves, rather than let their sugar levels climb throughthe night. Though medical laboratories could test blood samples for sugar content, patients and most doctors' offices could not. Instead, they relied on urine tests, which were far less accurate. For decades, the Clevelands and millions of other diabetics heated urine on kitchen stoves, then added a chemical solution that turned various colors depending on the amount of sugar. Any diabetics who were aggressive about controlling the illness ran a serious risk of taking too much insulin, which can push blood sugar low enough to cause a coma or death. The alternative was to let sugar levels run abnormally high, which over years damages many parts of the body.

Both brothers remain devout about diet and exercise, and have stayed remarkably active. Robert, a former accountant, is still an avid bicyclist. Gerald, who was the assistant schools superintendent in Syracuse, no longer plays tennis, but he regularly attends an exercise class for the elderly. Despite their caution, diabetes has given them frequent troubles and scares. When Gerald was in his 20's, a fever caused his blood sugar to soar, which, in turn, hindered his body's ability to heal and fight infection. He nearly died before doctors gave him a new drug, penicillin. Forty years ago, Robert went into a coma from low blood sugar and came near death after a hike in the Colorado Rockies. Just a few weeks ago, Gerald's blood sugar dipped low enough that he grew dizzy and fell in his apartment, and needed five stitches to close a gash on his head. The Clevelands have developed some of the circulatory and nerve problems in the feet that are so common to diabetics, and both have had some toes amputated. Gerald has undergone several operations for a rare condition, most prevalent in diabetics, that causes the hands to ball into fists. They also give much of the credit for their longevity to their wives, who helped them stick to the regimen and saved them from low-blood-sugar episodes. Robert's wife of 58 years, Ruth, is a nurse. ''She probably knows more about diabetes than anybody I know,'' he said.

Gerald's wife, Mildred, died in 2002, after 62 years of marriage, but even as she was dying, he said, she kept the habit of checking his skin during the night for the profuse sweat that might signal low blood sugar. ''One time when she had basically been bedridden for weeks, she found the strength to get up and go to the kitchen, and she poured orange juice and brought it back and made me drink it,'' he said. Both brothers make a point of meeting with younger diabetics, giving them hope and encouragement .''It hasn't been easy,'' Gerald said, ''but I've had a wonderful life.''

© New York Times

DATE: February 03, 2006

It's surprising when something that was once considered questionable for your health turns out to have health benefits, usually with the proviso to use it "in moderation." That happened with chocolate and alcohol, and now it is coffee's turn, reports the February issue of the Harvard Health Letter. Here's some of the mostly good news about coffee:

Blood pressure. Results from long-term studies are showing that coffee may not increase the risk for high blood pressure over time, as previously thought. Study findings for other cardiovascular effects are a mixed bag.

Cancer. Coffee might have anti-cancer properties. Last year, researchers found that coffee drinkers were 50% less likely to get liver cancer than nondrinkers. A few studies have found ties to lower rates of colon, breast, and rectal cancers.

Cholesterol. Two substances in coffee -- kahweol and cafestol -- raise cholesterol levels. Paper filters capture these substances, but that doesn't help the many people who now drink non-filtered coffee drinks, such as lattes. Researchers have also found a link between cholesterol increases and decaffeinated coffee, possibly because of the type of bean used to make certain decaffeinated coffees.

Diabetes. Heavy coffee drinkers may be half as likely to get diabetes as light drinkers or nondrinkers. Coffee may contain chemicals that lower blood sugar. A coffee habit may also increase your resting metabolism rate, which could help keep diabetes at bay.

Parkinson's disease. Coffee seems to protect men, but not women, against Parkinson's disease. One possible explanation for the sex difference may be that estrogen and caffeine need the same enzymes to be metabolized, and estrogen captures those enzymes.

The Harvard Health Letter is available from Harvard Health Publications, the publishing division of Harvard Medical School, for $28 per year. Subscribe at www.health.harvard.edu or by calling 1-877-649-9457 (toll free).

DATE: January 27, 2006

Gila monsters posses a unique protein in their venom that could eventually help treat diabetes in humans. Researchers are busy studying the lizards to find out how this protein works. "By understanding how this protein acts in this native organism, you can understand what more it would do in other animals," said researcher Carol Christel, while holding one of the lizards in her hands. Christel, a doctoral student at Arizona State University, hopes to write her dissertation on the digestive system of the United States' only poisonous lizard. She and Assistant Professor Dale Denardo were in Tuscaloosa this week to study with University of Alabama biology professor Stephen Secor, an expert on reptile digestion. Christel brought 18 of the lizards, found mostly in the southwestern states and northern Mexico, to the University of Alabama so Secor could study them. The lizard is a rare find in the wild. "We had the Gila monsters, and he had the expertise, so we just brought them together," Christel said. Denardo said the lizards are obtained when human development encroaches on their territory and they become a nuisance. Gila monsters are not able to adapt to new surroundings and perish soon after being moved to a new habitat, even just a few miles away, he said. Rather than allowing them to be killed, ASU takes them for research.

Gila monsters are one of only two poisonous lizards in the world. The other is the Mexican beaded lizard, similar to a Gila monster. Their venom is not as potent to humans as snake venom, but for the Gila's prey -- litters of rodents or rabbits -- it's enough. Gilas also eat bird eggs. Unlike humans, who eat at least twice a day, Gila monsters feast two or three times each year, Secor said. They then survive by storing fat in their tails. The protein, exendin-4, helps maintain and control insulin and glucose in the lizard during the long periods between meals. In humans, researchers found the protein lasts longer than other diabetes drugs, and the pharmaceutical company Amylin is developing an exendin-based drug. The lizard can make the protein by gnawing on anything but fortunately for the Gila monster, the protein can also be made synthetically. The research at the University of Alabama is not geared toward creating a patent or drug, but toward further understanding how the protein works in the lizard.

DATE: January 20, 2006

It's been said laughter is the best medicine, but no one has yet proven it. Now a Japanese scientist is unlocking the secrets of the funny bone, which he believes can cheer up people's genes. Geneticist Kazuo Murakami has teamed up on the study with unlikely research partners: Stand-up comedians, who he hopes -- no joke -- can turn their one-liners into efficient, low-cost medical treatment.

Genes are usually regarded as immutable, but in reality more than 90 percent of them are dormant or less active in producing protein, so some types of stimulation can wake them up. Murakami's tentative theory is that laughter is one such stimulant, which can trigger energy inside a person's DNA, potentially helping to cure disease. "If we can prove people can switch genes on and off by an emotion like laughter, it may be the finding of the century which should be worth the Nobel Prize or even go beyond that," said Murakami, 70, director of Japan's Foundation for the Advancement of International Science. Three years ago, Murakami and Yoshimoto Kogyo Co. Ltd., a leading entertainment company, jointly carried out their first experiment in which they let diabetics laugh at a comedy show performed by the firm's top stand-up comedians after listening to a monotonous college lecture. The two day experiment showed that their blood glucose levels -- a key gauge for the development of diabetes -- became lower after they laughed compared with after they listened to the lecture. His latest experiment with the entertainment firm spotted at least 23 genes that can be activated. Eighteen of them are designed to work for immune response, signal transduction and the cell cycle, while functions of the remaining five others are still unknown. The findings, which Murakami says are the first of their kind, are scheduled to be published soon in Psychotherapy and Psychosomatics, a U.S. academic journal. "Laughing therapy has no side effects, meaning it's an epoch making treatment for clinical medicine," he said. "One day it won't be a joke to see patients receive a prescription for a comedy video at a pharmacy for medical treatment. "Watch two of these and call me in the morning': Having a good laugh has long been thought of as therapeutic. Laughter has been taught by yoga masters in India, home to a growing number of "laughing clubs" whose members get together just to enjoy a chuckle. Expectations from Murakami's research are particularly high in Japan, where medicare costs are increasing year after year as the country's population rapidly ages. Even with the research still in its early stages, a Japanese medical publisher, under the editorial guidance of Murakami's research team, began selling DVDs last year instructing patients with diabetes on how to laugh.

The Ministry of Economy, Trade and Industry believes that laughter therapy could be put to good use in a project as demand grows for preventive medical care. "If the relation between laughter and health is proved scientifically, it may have a big impact on ways to improve health," said Hikaru Horiguchi, an official of the ministry. "We also hope that a new type of industry will be created by linking the two different fields -- laughter and medical treatment," Horiguchi said. With the ministry's financial support, Osaka Sangyo University in western Japan formed a joint venture with researchers, firms and doctors in 2004 to provide elderly people with a complete medical care program combining physical training and laughter therapy. "It was the nation's first attempt to launch a medicare business with laughter in collaboration with the government, industry and academe," said Mitsutoshi Nishikawa, a university official in charge of the "Daito Dynamic Project" based in Daito city in Osaka. Nishikawa said Osaka was an ideal location to launch the project as the city is famous for its humor culture, with residents here said to be less hesitant to laugh in public than more taciturn Tokyo. "We believe there is a big business chance here," Nishikawa said. "With the project, we can expect a reduction in medicare and nursing costs," he said. "Moreover, it's important for elderly people to live long with good health." In the program, participants receive a medical check-up and gymnastic exercises while enjoying a comedy show performed by professional comedians. It also offers them cooking classes on making healthy foods. "I used to laugh a lot when I was young, but I realized that I had not laughed much since getting older," said Kiyomi Yamanaka, a 61-year-old housewife participating in the program. "But after attending the event, my blood flow has become smooth and I can now get down on my knees, which I couldn't do before." <>According to project officials, the 92 participants polled said their combined annual medicare costs fell 23 percent to 2.26 million yen ($19,800) after they joined the program. Nishikawa said, "In the future, we want to make medical treatment something not gloomy but fun. That's our goal."

DATE: January 13, 2006

A new cell-phone-sized eye scanner could soon provide an easy way for diabetics to monitor their blood sugars. It could eventually remove the need for painful pinprick tests on their fingers in order to measure blood glucose levels. The device is currently under development by Oculir Inc., a new San Diego California based company. Their new technology uses infrared light to measure glucose levels from a scan of the white of the eye. A person with diabetes would simply hold the device close to their eye, allowing IR radiation technology to test their glucose level.

Oculir's CEO, Dr. John Burd, recently stated, "We all give off Mid-IR radiation as heat We have done a very small number of human studies with our research instrumentation and the results are very encouraging. We are now getting ready to run larger human trails and work on a commercial unit. People have been working on a non-invasive glucose test for decades and we think we've learned from their mistakes and we're coming up with a great product."

DATE: January 06, 2006

Patients taking two widely used diabetes drugs have reported blurry vision and swelling of the legs and feet, the FDA and the drugs manufacturer, GlaxoSmithKline, announced this week. The company, with U.S. offices in both Research Triangle Park, N.C., and Philadelphia, P.A., said it has received "very rare" reports of new or worsening diabetic macular edema in diabetic patients who have taken Avandia or Avandamet. The swelling of the portion of the retina most important for sight can cause blurry or distorted vision.

The majority of those patients also reported peripheral edema, or swelling of the legs, ankles and feet, the company said in a letter sent out to prescribing doctors last month. In some cases, stopping treatment or reducing the dose eliminated or improved the condition, it added.

Avandia and Avandamet both contain the drug rosiglitazone. More than six million people worldwide have taken either drug.

GlaxoSmithKline: www.gsk.com

Food and Drug Administration: www.fda.gov