Diabetes News from dLife.com

Researchers Find Possible Environmental Causes For Alzheimer's, Diabetes

2009-07-05T14:48:44Z

July 5, 2009 (EurekAlert) - A new study by researchers at Rhode Island Hospital have found a substantial link between increased levels of nitrates in our environment and food with increased deaths from diseases, including Alzheimer's, diabetes mellitus and Parkinson's. The study was published in the Journal of Alzheimer's Disease (Volume 17:3 July 2009).

Led by Suzanne de la Monte, MD, MPH, of Rhode Island Hospital, researchers studied the trends in mortality rates due to diseases that are associated with aging, such as diabetes, Alzheimer's, Parkinson's, diabetes and cerebrovascular disease, as well as HIV. They found strong parallels between age adjusted increases in death rate from Alzheimer's, Parkinson's, and diabetes and the progressive increases in human exposure to nitrates, nitrites and nitrosamines through processed and preserved foods as well as fertilizers. Other diseases including HIV-AIDS, cerebrovascular disease, and leukemia did not exhibit those trends. De la Monte and the authors propose that the increase in exposure plays a critical role in the cause, development and effects of the pandemic of these insulin-resistant diseases.

De la Monte, who is also a professor of pathology and lab medicine at The Warren Alpert Medical School of Brown University, says, "We have become a 'nitrosamine generation.' In essence, we have moved to a diet that is rich in amines and nitrates, which lead to increased nitrosamine production. We receive increased exposure through the abundant use of nitrate-containing fertilizers for agriculture." She continues, "Not only do we consume them in processed foods, but they get into our food supply by leeching from the soil and contaminating water supplies used for crop irrigation, food processing and drinking."

Nitrites and nitrates belong to a class of chemical compounds that have been found to be harmful to humans and animals. More than 90 percent of these compounds that have been tested have been determined to be carcinogenic in various organs. They are found in many food products, including fried bacon, cured meats and cheese products as well as beer and water. Exposure also occurs through manufacturing and processing of rubber and latex products, as well as fertilizers, pesticides and cosmetics.

Nitrosamines are formed by a chemical reaction between nitrites or other proteins. Sodium nitrite is deliberately added to meat and fish to prevent toxin production; it is also used to preserve, color and flavor meats. Ground beef, cured meats and bacon in particular contain abundant amounts of amines due to their high protein content. Because of the significant levels of added nitrates and nitrites, nitrosamines are nearly always detectable in these foods. Nitrosamines are also easily generated under strong acid conditions, such as in the stomach, or at high temperatures associated with frying or flame broiling. Reducing sodium nitrite content reduces nitrosamine formation in foods.

Nitrosamines basically become highly reactive at the cellular level, which then alters gene expression and causes DNA damage. The researchers note that the role of nitrosamines has been well-studied, and their role as a carcinogen has been fully documented. The investigators propose that the cellular alterations that occur as a result of nitrosamine exposure are fundamentally similar to those that occur with aging, as well as Alzheimer's, Parkinson's and Type 2 diabetes mellitus.

De la Monte comments, "All of these diseases are associated with increased insulin resistance and DNA damage. Their prevalence rates have all increased radically over the past several decades and show no sign of plateau. Because there has been a relatively short time interval associated with the dramatic shift in disease incidence and prevalence rates, we believe this is due to exposure-related rather than genetic etiologies."

The researchers recognize that an increase in death rates is anticipated in higher age groups. Yet when the researchers compared mortality from Parkinson's and Alzheimer's disease among 75 to 84 year olds from 1968 to 2005, the death rates increased much more dramatically than for cerebrovascular and cardiovascular disease, which are also aging-associated. For example, in Alzheimer's patients, the death rate increased 150-fold, from 0 deaths to more than 150 deaths per 100,000. Parkinson's disease death rates also increased across all age groups. However, mortality rates from cerebrovascular disease in the same age group declined, even though this is a disease associated with aging as well.

De la Monte notes, "Because of the similar trending in nearly all age groups within each disease category, this indicates that these overall trends are not due to an aging population. This relatively short time interval for such dramatic increases in death rates associated with these diseases is more consistent with exposure-related causes rather than genetic changes." She also comments, "Moreover, the strikingly higher and climbing mortality rates in older age brackets suggest that aging and/or longer durations of exposure have greater impacts on progression and severity of these diseases."

The researchers graphed and analyzed mortality rates, and compared them with increasing age for each disease. They then studied United States population growth, annual use and consumption of nitrite-containing fertilizers, annual sales at popular fast food chains, and sales for a major meat processing company, as well as consumption of grain and consumption of watermelon and cantaloupe (the melons were used as a control since they are not typically associated with nitrate or nitrite exposure).

The findings indicate that while nitrogen-containing fertilizer consumption increased by 230 percent between 1955 and 2005, its usage doubled between 1960 and 1980, which just precedes the insulin-resistant epidemics the researchers found. They also found that sales from the fast food chain and the meat processing company increased more than 8-fold from 1970 to 2005, and grain consumption increased 5-fold.

The authors state that the time course of the increased prevalence rates of Alzheimer's, Parkinson's and diabetes cannot be explained on the basis of gene mutations. They instead mirror the classical trends of exposure-related disease. Because nitrosamines produce biochemical changes within cells and tissues, it is conceivable that chronic exposure to low levels of nitrites and nitrosamines through processed foods, water and fertilizers is responsible for the current epidemics of these diseases and the increasing mortality rates associated with them.

De la Monte states, "If this hypothesis is correct, potential solutions include eliminating the use of nitrites and nitrates in food processing, preservation and agriculture; taking steps to prevent the formation of nitrosamines and employing safe and effective measures to detoxify food and water before human consumption."

'Jumping Gene' Diminishes the Effect of a New Type 2 Diabetes Risk Gene

2009-07-02T14:51:28Z

July 2, 2009 (EurekAlert) - Research led by the German Institute of Human Nutrition (DIfE) has identified a new gene associated with diabetes, together with a mechanism that makes obese mice less susceptible to diabetes. A genomic fragment that occurs naturally in some mouse strains diminishes the activity of the risk gene Zfp69. The researchers also found that the corresponding human gene (ZNF642) is especially active in overweight individuals with diabetes. The results of the study, which also involved scientists from the University of Leipzig and the German Cancer Research Center in Heidelberg, are published July 3 in the open-access journal PLoS Genetics.

According to the World Health Organization (WHO), around 1.6 billion people are overweight worldwide. The number of people with type 2 diabetes has increased accordingly to 230 million. The risk of developing type 2 diabetes is approximately 50% hereditary, but is also dependent on nutrition and lifestyle factors.

In the present study, the researchers compared the genomes of different mouse strains. Some mouse strains were obese but had no strikingly elevated blood glucose levels and were less susceptible to diabetes. Other strains developed a severe malfunction of fat and glucose metabolism as they continued to gain weight, causing these mice to rapidly develop type 2 diabetes.

According to the study, this difference is due to a small fragment of genetic information: a so-called "jumping gene" or "transposon" of viral origin, localized in a non-coding segment of the gene Zfp69, whose effect it diminishes. Without this genetic fragment, the risk gene is fully active and, in combination with obesity, leads to high blood sugar levels and malfunction of fat metabolism. The gene is also active in the fat tissues of overweight people suffering from diabetes – more so than in healthy individuals.

"Our data suggest that the protein product of the risk gene in obese individuals enhances the storage of fat in fat cells. As a result, excessive fat accumulates in the liver and this in turn contributes to the development of diabetes," explains Stephan Scherneck, first author of the study.

"We have therefore discovered a new diabetes gene of similar importance in mice and humans," says Hans-Georg Joost, head of the study and scientific director of DIfE, "as well as a mechanism that has not been described before in connection with the heredity of diabetes and obesity."

These data show the importance of studying in detail not only genes themselves but also transposons in their vicinity.

Joost continued, "This transposon is quite active and almost completely "turns off" the Zfp69 gene. We have found indications that it is also active in other mouse genes. Since the human genome is full of such fragments, it is quite possible that they play a greater role than previously assumed."

Early Communication About Safety of Lantus (insulin glargine)

2009-07-01T18:43:24Z

July 1, 2009 (FDA) - FDA is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. See http://www.diabetologia-journal.org/cancer.html.

Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects. Patients should also contact their healthcare professional if they have concerns about the medicines they are taking.

Similar to human insulin, insulin glargine is used to control blood sugar in people with Type 1 and Type 2 diabetes. Insulin glargine, however, is a modified version of human insulin (an insulin analogue) that allows for the control of blood sugar for extended periods of time (a long-acting insulin). Insulin glargine is approved for once-a-day dosage by subcutaneous injection (injection under the skin).

The four observational studies evaluated large patient databases and all reported some level of association between the use of insulin glargine, and other insulin products, and various types of cancer. The duration of patient follow-up in all four studies was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure. Further, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.

FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus.

Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed.

FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.

The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program using the information at the bottom of the page.

This early communication is in keeping with FDA’s commitment to informing the public about its ongoing safety reviews of drugs. FDA will communicate its findings with the public as soon as its review of insulin glargine is complete.

This information reflects FDA’s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

Young Black Women Prone to Gain More Unhealthy Abdominal

2009-07-01T17:41:31Z

July 1, 2009 (Press Release) - Black women ages 20 to 29 are more prone to pack on unhealthy abdominal and visceral fat than Hispanic women the same age, and as compared to their elders, according to researchers from Wake Forest University Baptist Medical Center and colleagues.

The new research shows that accumulation of abdominal fat that increases risk of type 2 diabetes is greatest in young adulthood for blacks and Hispanics, said endocrinologist Kristen G. Hairston, M.D., M.P.H., lead author of an article published online June 1 by the American Diabetes Association. The study is the first to look at a large minority cohort using computed tomography (CT) scanning to measure longitudinal changes over time in visceral and subcutaneous adipose tissue, which are different types of abdominal fat.

The study followed 389 blacks and 844 Hispanics ages 20 to 69, men and women, grouped by age in 10-year increments. The researchers took baseline measurements of visceral adipose tissue (VAT) and subcutaneous abdominal tissue (SAT) from 1999 to 2002 with follow-up measurements in 2005-2007. VAT is fat that resides within the abdominal cavity around internal organs and has been linked to metabolic disturbances. SAT is the kind of fat that one can pinch, like “love handles.”

The study found that the young adult age group (ages 20 to 29) had the largest five-year increase in measured adiposity, or fat, regardless of race or gender. The increase in VAT averaged 18 and 12 square centimeters (cm2) among young black and Hispanic women, respectively, and 13 and 7 cm2 among young men. The five-year increase in (SAT) was 89 and 53 cm2 among young black and Hispanic women, respectively, and 76 and 30 cm2 among young men. In general, fat accumulation declined in the older age groups. Abdominal fat accumulation, particularly the visceral type, is significant because previous studies show that VAT changes of this magnitude differentiate those who develop diabetes from those who don’t.

Until this study, this pattern of excessive abdominal fat accumulation in young adults has not been reported using CT-measured “fat depots.” The findings, however, are consistent with several other studies that used measurements such as body mass index and waist circumference. In this study, abdominal tissue area was measured at the L4/L5 vertebral region by CT.

“Our data may help to further identify unique populations at risk for type 2 diabetes and those for whom behavioral intervention might be most effective,” said Hairston, assistant professor of endocrinology and metabolism.

Grants from the National Institutes of Health funded the research. The article, titled “Five-year change in visceral adipose tissue quantity in a minority cohort: The IRAS Family Study,” appears online at http://care.diabetesjournals.org/content/early/2009/05/28/dc09-0336.abstract. It will be published in the August issue of Diabetes Care, a publication of the American Diabetes Association.

Co-authors include Capri Foy, Ph.D., Orita McCorkle, B.A., and Lynne Wagenknecht, DrPH, from Wake Forest Baptist; Ann Scherzinger, Ph.D., and Jill Norris, M.P.H., Ph.D., from University of Colorado-School of Health Sciences; Anthony Hanley, Ph.D., from University of Toronto, Nutrition Sciences; Steven Haffner, M.D., M.P.H., University of Texas-Health Science Center at San Antonio; and Michael Bryer-Ash from University of Oklahoma School of Health Sciences.

UT Researcher: Interferon Alpha Can Delay Full Onset of Type I Diabetes

2009-07-01T15:29:16Z

July 1, 2009 (EurekAlert) - A low dose of oral interferon alpha shows promise in preserving beta cell function for patients with newly diagnosed type 1 diabetes, or juvenile diabetes, according to researchers at The University of Texas Medical School at Houston.

The results of the Phase II trial are published today in Diabetes Care, a journal of the American Diabetes Association.

"It shows a strong trend in preserving insulin-producing beta cell function that is significantly better than placebo," said Staley Brod, M.D., principal investigator of the trial, which includes the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). "It can extend the 'honeymoon phase' of the disease, allowing the body to still produce insulin from beta cells, which correlates with decreased complication rates."

As many as 3 million Americans may have type I diabetes, formerly called juvenile diabetes, according to the Juvenile Diabetes Research Foundation International. Each year, 15,000 children are diagnosed with the autoimmune disease, in which the pancreas stops producing the insulin needed to transfer glucose from the blood to cells for energy. The result is too much glucose in the blood, which can lead to kidney failure, blindness, nerve damage, amputations, heart attack and stroke.

A honeymoon phase sometimes occurs just after diagnosis as the body tries to rebound. Many patients experience a period when their need for insulin becomes minimal, control of blood sugar improves and beta cells partially recover. If the pancreas is still able to function, the highs and lows experienced by taking manufactured insulin can be decreased.

The Phase II trial included 128 patients from the NIDDK's Intramural Studies Office, The University of Texas Southwestern Medical Center in Dallas and Children's Hospitals and Clinics in Minneapolis/St. Paul, Minn. Research was conducted at The University of Texas Clinical Research Center at Memorial Hermann-Texas Medical Center, which is part of the Center for Clinical and Translational Sciences at The University of Texas Health Science Center at Houston.

Research subjects ages 3 to 25 diagnosed with type 1 diabetes within six weeks of enrollment were randomized to receive 5,000 units of interferon alpha, 30,000 units of interferon alpha or placebo once daily for one year. Patients treated with 5,000 units lost only 29 percent of their beta cell function compared to 48 percent for patients receiving 30,000 units and 56 percent for patients receiving the placebo.

Austin resident Jarod Wallquist, 11, was 5 years old when he was diagnosed with type I diabetes and his mother Amy learned about Brod's study. Jarod received the 5,000 units of interferon alpha, but neither she nor the researchers knew it at the time because of the double-blind nature of the study.

"My husband and I are both scientific-minded so we understood the importance of the research even if we didn't know whether it would help Jarod," said Wallquist, whose family made regular trips to Houston for the study. "Jarod is doing really well. He wears an insulin pump but he's never had to go to the emergency room. To this day, according to his doctor, his amount of insulin needed is much lower than other kids his age and weight. He plays baseball and is on the swim team and he totally has a normal life."

The research builds on Brod's earlier studies on oral interferon alpha in animals and a Phase I safety trial. After the results of the safety trial, NIDDK researchers asked to join Brod's research before the Phase II trial.

Brod's theory is that autoimmune diseases, which occur when the body is attacked by its own immune system, are actually an alpha interferon immunodeficiency syndrome. Interferons are a group of proteins produced by cells in response to an attack by a virus.

Joint Replacement Patients with Diabetes Greatly Benefit From Controlled Glucose

2009-07-01T15:22:53Z

July 1, 2009 (EurekAlert) - Diabetics undergoing total joint replacement often are at a higher risk of experiencing complications after surgery due to various pre-existing health conditions. According to a new study published in the July 2009 issue of The Journal of Bone and Joint Surgery (JBJS), those complications are less likely to occur when a diabetic patient has glucose levels under control.

"We found that controlled glucose levels really do make a difference for the patient," said study co-author Milford Marchant Jr., MD, an orthopaedic surgeon who conducted the study with colleagues of the Adult Reconstruction Section at Duke University Medical Center.

The study found that patients with uncontrolled glucose levels were:

* More than 3 times as likely to experience a stroke or death after joint replacement surgery; and
* About twice as likely to experience post-operative bleeding and infection.

Dr. Marchant and his colleagues reviewed data from a national healthcare database looking at more than one million patients who had total joint replacement surgery from 1988 to 2005. They compared surgical outcomes in patients with uncontrolled glucose levels to those who had controlled glucose levels and those patients who did not have diabetes.

"It did not matter if the patient had Type I or Type II diabetes," explains Dr. Marchant. "Regardless of diabetes type, we found that patients had fewer complications after surgery if their glucose level was controlled before, during and after surgery."

Diabetic patients with uncontrolled glucose were more likely to experience surgical complications, infection, blood transfusions and longer hospitals stays.

"The factors necessary for diabetic patients to be considered 'under control' are different for each individual patient, therefore diabetic patients should have good relationships with their medical doctors," said Dr. Marchant.

Study authors say that according to the American Diabetes Association, disease control is determined for each patient based on a series of laboratory blood tests and an assessment of diabetes-related illnesses. Approximately 8 percent of patients undergoing total hip and knee replacement in the United States have diabetes.

"It is crucial that patients have glucose levels well managed before, during and after surgery because it reduces the potential of having a complication," notes Dr. Marchant. "This is the responsibility of both the patient and the surgeon, and it should be a priority."

U of Minnesota Finds Treatment That Significantly Slows Progression of Eye Damage in Persons with Type 1 Diabetes

2009-07-01T15:21:01Z

July 1, 2009 (EurekAlert) - University of Minnesota Medical School researcher Michael Mauer, M.D., has found a treatment that significantly slows the progression of eye injury in people with type 1 diabetes, a common complication caused by this disease. By administering an antihypertensive, medication commonly prescribed to treat high blood pressure, Mauer and colleagues were able to slow progression of diabetic eye damage in more than 65 percent of participants involved in the study.

Diabetes is the primary cause of acquired blindness in adults and accounts for nearly half of all new cases of chronic kidney failure in the Unites States each year, and people living with the disease often struggle with these complications as it progresses. Previous studies of people with type 1 diabetes who were already exhibiting symptoms of vision and kidney function loss showed that these types of antihypertensive medications slowed further function loss in the kidneys, but often could not prevent kidney failure. Mauer and colleagues were interested in testing whether or not they could delay diabetic kidney injury in participants who had normal blood pressure and had not yet shown signs of kidney disease at the beginning of the study.

Three groups of participants were observed over the course of five years. Two groups were administered one of two antihypertensive medications, losartan or enalapril, and the last group, a placebo. The results were unexpected, but conclusive. Mauer's study demonstrated that these drugs did not protect the participants' kidneys from damage or from losing function. However, participants who were administered either enalapril or losartan experienced a significant slowing of the progression of diabetic eye injury, by 65 and 70 percent, respectively.

"The secondary results of this study showed that people taking these antihypertensive medications experienced a substantially positive effect in slowing diabetic eye injury," said Mauer, professor of pediatrics and medicine in the Medical School. "Although neither medication delayed early kidney tissue injury or early loss of kidney function, the advantage to a study with negative findings such as this one is that physicians now know that this treatment is ineffective for this purpose, and they can pursue other treatment options that may improve their patients' outcomes."

Although the data does not support the use of these types of antihypertensives to prevent kidney damage in people living with diabetes, Mauer and colleagues find it reasonable for physicians to consider prescribing these classes of medication to people with type 1 diabetes in order to slow the onset and progression of diabetic eye disease. He notes, though, that this also poses several other unanswered questions such as at what age a person with diabetes should be prescribed this class of drug and how long they should continue taking it.

Lap-Band Weight-Loss Surgery Can Reverse Metabolic Syndrome in Obese Teens

2009-07-01T15:18:42Z

July 1, 2009 (EurekAlert) - A new study of obese adolescents has shown that laparoscopic gastric banding surgery -- the "Lap-Band" procedure -- not only helps them achieve significant weight loss but can also improve and even reverse metabolic syndrome, reducing their risk for cardiovascular disease and diabetes.

Metabolic syndrome is defined as a cluster of risk factors -- high blood pressure; low levels of HDL or "good" cholesterol; excessive abdominal fat; and elevated levels of blood sugar, C-reactive protein and triglycerides -- that increase a person's chances of developing cardiovascular disease or diabetes later in life. The single biggest risk factor is obesity, and metabolic syndrome usually improves when a person loses weight.

The study was led by Drs. Ilene Fennoy, Jeffrey Zitsman and colleagues at NewYork-Presbyterian Morgan Stanley Children's Hospital and Columbia University Medical Center and presented at the annual Endocrine Society meeting in Washington, D.C.

"An estimated 17 percent of all American adolescents are obese, and increasing numbers of them also have metabolic syndrome," says Dr. Fennoy, a pediatric endocrinologist at NewYork-Presbyterian Morgan Stanley Children's Hospital, clinical professor of pediatrics at the Columbia University College of Physicians and Surgeons and co-author of the study. "Until recently, there have been few treatments capable of helping these young patients lose weight, much less improving their lifelong health prospects. The Lap-Band may well be a useful intervention for tackling teen obesity -- which is why it is so important to investigate the procedure's safety and efficacy in this growing population."

In the new study, Dr. Fennoy and her colleagues followed 24 morbidly obese adolescents between the ages of 14 and 17 who underwent the Lap-Band procedure. The study participants either had a BMI of greater than 40 or greater than 35 if already suffering from diabetes or obesity-related illnesses.

Six months after surgery, they noted a significant drop in participants' BMI, waist circumference, and blood levels of C-reactive protein. These indicators continued to improve among the 12 patients being followed up at the one-year point.

Other measures of metabolic syndrome such as blood lipid and sugar levels, the authors reported, came down quickly in the first six months, with "less dramatic" changes seen one year after surgery.

"Of all the bariatric procedures," she says, "the Lap-Band is the most benign, with complication rates of less than 1 percent." The device, inserted via minimally invasive laparoscopic surgery, consists of a simple band to make the stomach smaller and a balloon that can be decompressed when necessary, she explains.

Although it is technically reversible, the procedure should be considered a long-term solution for extreme and intractable obesity.

The Lap-Band is the favored bariatric procedure in Europe, while in the U.S., gastric bypass has been the preferred approach. At present, NewYork-Presbyterian Morgan Stanley Children's Hospital/Columbia University Medical Center is one of a few medical centers offering the Lap-Band option in this country.

The Lap-Band procedure, an approved treatment for adults with extreme obesity, has not yet been thoroughly studied in adolescents. Larger, multicenter studies with longer follow-up periods will be needed, Dr. Fennoy says, to validate the findings of the current study.

ADA Releases Updated Position Paper on Vegetarian Diets

2009-07-01T15:16:13Z

July 1, 2009 (EurekAlert) - The American Dietetic Association has released an updated position paper on vegetarian diets that concludes such diets, if well-planned, are healthful and nutritious for adults, infants, children and adolescents and can help prevent and treat chronic diseases including heart disease, cancer, obesity and diabetes.

ADA's position, published in the July issue of the Journal of the American Dietetic Association, represents the Association's official stance on vegetarian diets:

"It is the position of the American Dietetic Association that appropriately planned vegetarian diets, including total vegetarian or vegan diets, are healthful, nutritionally adequate and may provide health benefits in the prevention and treatment of certain diseases. Well-planned vegetarian diets are appropriate for individuals during all stages of the life-cycle including pregnancy, lactation, infancy, childhood and adolescence and for athletes."

ADA's position and accompanying paper were written by Winston Craig, PhD, MPH, RD, professor and chair of the department of nutrition and wellness at Andrews University; and Reed Mangels, PhD, RD, nutrition advisor at the Vegetarian Resource Group, Baltimore, Md.

The revised position paper incorporates new topics and additional information on key nutrients for vegetarians, vegetarian diets in the life cycle and the use of vegetarian diets in prevention and treatment of chronic diseases. "Vegetarian diets are appropriate for all stages of the life cycle," according to ADA's position. "There are many reasons for the rising interest in vegetarian diets. The number of vegetarians in the United States is expected to increase over the next decade."

Vegetarian diets are often associated with health advantages including lower blood cholesterol levels, lower risk of heart disease, lower blood pressure levels and lower risk of hypertension and type 2 diabetes, according to ADA's position. "Vegetarians tend to have a lower body mass index and lower overall cancer rates. Vegetarian diets tend to be lower in saturated fat and cholesterol and have higher levels of dietary fiber, magnesium and potassium, vitamins C and E, folate, carotenoids, flavonoids and other phytochemicals. These nutritional differences may explain some of the health advantages of those following a varied, balanced vegetarian diet."

The position paper draws on results from ADA's evidence analysis process and information from the ADA Evidence Analysis Library to show vegetarian diets can be nutritionally adequate in pregnancy and result in positive maternal and infant health outcomes. Additionally, an evidence-based review showed a vegetarian diet is associated with a lower risk of death from ischemic heart disease.

A section in ADA's paper on vegetarian diets and cancer has been significantly expanded to provide details on cancer-protective factors in vegetarian diets. An expanded section on osteoporosis includes roles of fruits, vegetables, soy products, protein, calcium, vitamins D and K and potassium in bone health. "Registered dietitians can provide information about key nutrients, modify vegetarian diets to meet the needs of those with dietary restrictions due to disease or allergies and supply guidelines to meet needs of clients in different areas of the life cycle," the authors said.

AACE Response to Insulin Glargine Cancer Risk Articles in Diabetologia

2009-06-30T22:19:49Z

June 29, 2009 (Press Release) - On June 26, 2009 several articles published online in Diabetologia by the European Association for the Study of Diabetes investigated the possible relationship between use of insulin glargine (Lantus, sanofi-aventis) and the development of certain malignancies. The authors themselves, and the accompanying editorial, cautioned against over-interpretation of their limited data and analyses, which precluded them from drawing any firm conclusions. For example, there were contradictory findings among the studies, patient populations were not always comparable, and the duration of observation was short. Nonetheless, since the relationship of type 2 diabetes to cancer is of critical importance, further study is warranted.

The American Association of Clinical Endocrinologists (AACE) does not recommend that the use of any insulin be changed. AACE supports further research into the effectiveness and safety of all diabetes therapies and will continue to update recommendations as further data becomes available. Individual patient concerns should be discussed with their physicians.

Possible Link Between Insulin Glaragine and Cancer Prompts Urgent Call for More Research

2009-06-30T19:45:28Z

June 30, 2009 (Diabetologia) - Worldwide, there are over 200 million people with diabetes. About 10% of these develop diabetes in early life, and most of them have what is known as type 1 diabetes. People with type 1 diabetes have an absolute reliance upon insulin treatment for their continued health and well-being. Type 2 diabetes, which affects the remaining 90%, typically develops later in life and may be associated with excess weight. People with type 2 diabetes are able to make some of their own insulin, which means that they can usually be treated with diet and tablets in its early stages. At a later stage, however, many patients with type 2 diabetes lose the ability to produce their own insulin, and will then need insulin injections to maintain their health.

Human insulin has been widely used for decades and its safety is beyond doubt; this new information relates to an artificial form of insulin, or insulin analogue, called insulin glargine (or Lantus insulin) which has been widely used since 2000. The concerns about a possible link between use of Lantus insulin and increased cancer risk were raised by a German study of around 127,000 insulin-treated patients in an insurance database. The research identified a statistically significant link between patients who had used Lantus insulin and those who had been diagnosed with cancer. Compared with people using similar doses of human insulin, out of every 100 people who used Lantus insulin over an average of about one-and-a-half years, one additional person was diagnosed with cancer. Of particular note in this study was the finding that the increased risk of cancer was dose-dependent. Thus for patients given a dose of 10U, Lantus insulin alone increased the risk of cancer by 9% compared with human insulin; but for a dose of 50U, the increased risk was 31%. The study did not consider insulin detemir (Levemir), an insulin analogue whose action is prolonged by a different principle from Lantus.

Professor Edwin Gale, Editor of Diabetologia, and Professor Ulf Smith, President of EASD, realised the significance of these findings but wanted them replicated in other studies from other European countries before announcing them formally. Studies were thus carried out using databases from Sweden, Scotland, and the UK. The Swedish study found that compared with patients on insulins other than Lantus insulin, patients on lantus insulin alone had double the risk of breast cancer. The Scottish study found a non-significant increased risk for breast cancer specifically. The UK study found no link between insulin glargine and cancer.

Prof Gale and Prof Smith emphasise the limitations to the studies. The main one is that, although the data were adjusted for a number of variables, the characteristics of the groups of patients taking lantus insulin alone (generally older, higher blood pressure, more overweight) were different to those on other forms of insulin. Thus any difference in cancer risk could be attributed to the pre-treatment characteristics of the groups, rather than the treatment itself. Also, the numbers of cases of breast cancer in the Swedish and Scottish studies were very small, meaning the findings could have occurred due to chance. They state categorically that Lantus and other insulins do not cause cancer, but these studies expose the possibility that Lantus insulin could cause existing cancer cells to grow and divide more rapidly-which might explain why more cancers came to be diagnosed over 1-3 years of observation. They say: "We believe people are entitled to know that use of Lantus insulin might be associated with greater risk, but this must also be balanced against the possibility that we might be causing unnecessary alarm by raising these concerns."

To establish whether these concerns are warranted or can be set aside, EASD have communicated their findings to EMEA, the European regulatory authorities, and are in contact with sanofi-aventis, the manufacturers of Lantus insulin. While a prospective clinical trial would be the most scientifically sound manner to proceed, Profs Gale and Smith say such a trial would be slow, unfeasible and unethical. They say: "A large combined analysis of the best available databases worldwide is the best way forward, and EASD and sanofi-aventis are pledged to carry this investigation forward until we have either confirmed these preliminary observations or, more hopefully, finally put them to rest."

While this research is awaited, EASD advises that patients do not stop taking Lantus insulin on the basis of the findings reported here. However, since Lantus does not offer better overall glucose control than human insulin in type 2 diabetes, patients can consider alternatives. In an advice leaflet published with the studies, Profs Gale and Smith say: "People with diabetes do however have the option of using long acting human insulin or a mixture of long- and short-acting human insulin twice a day instead of the once-daily analogue. You may wish to consider this option if you already have a cancer, or, for women, if there is a family history of breast cancer. You should not make any change in your insulin treatment without consulting your own doctor, and you should on no account stop taking your insulin."

Statement From IDF on Studies Suggesting Possible Link Between Insulin Glargine and Cancer

2009-06-30T15:27:28Z

June 29, 2009 (EurekAlert) - The International Diabetes Federation (IDF) today called for urgent assessment and responses from regulatory authorities into a possible link between the use of insulin glargine (an insulin analogue) and increased risk of cancer based on findings published on 26 June, 2009 in Diabetelogia, the journal of the European Association for the Study of Diabetes (EASD).

The online data published in Diabetelogia is based on four studies relating to a possible link between a long-acting insulin analogue, insulin glargine and cancer. According to EASD, the findings are based on evidence from studies in Germany, Sweden, Scotland and the United Kingdom. The studies however, are not conclusive.

The International Diabetes Federation understands the concern about the Diabetelogia study findings but urges the diabetes community to wait for the current scientific information to be released and calls for urgent further scientific studies to be undertaken in other countries.

The International Diabetes Federation stresses that it is important that people needing insulin do not stop taking the drug. IDF cautioned that people with diabetes should see their doctor for advice before considering any change to their treatment.

Hypoglycemia During Hospitalization Linked to Higher Mortality Risk

2009-06-29T15:03:29Z

June 29, 2009 (Brigham and Women's) - Researchers at Brigham and Women’s Hospital (BWH) found that diabetics hospitalized for non-critical illnesses who develop hypoglycemia during hospitalization have an increased likelihood of remaining hospitalized longer and a greater risk of mortality both during and after hospitalization. This research appears in the July 2009 issue of Diabetes Care.

Previous research showed an increased risk of mortality, seizures and coma in patients who, while admitted to the intensive care unit (ICU), developed hypoglycemia. “Ours is the first study to examine mortality risks for hospitalized diabetes patients outside of a critical care setting,” said Alexander Turchin, MD, of the Endocrinology Department at BWH. “This is crucial because a majority of hospitalized diabetics are treated on the general ward rather than the ICU.”

Researchers examined the medical records of more than 2,500 diabetics admitted to the general ward of a teaching hospital. They studied the association between the number and severity of hypoglycemic episodes with inpatient mortality, length of hospital stay and mortality within one year of discharge.

This study found that for each hospital day with at least one hypoglycemic episode, there was an 85.3 percent increased risk of dying as an inpatient and a 65.8 percent increased risk of dying within one year of discharge. The odds of inpatient death also tripled for every 10 mg/dl decrease in the lowest blood glucose during hospitalization. Additionally, a patient’s length of stay increased by 2.5 days for each day spent in the hospital with a hypoglycemic episode.

“Hypoglycemia is common among diabetics admitted to the general ward,” said Dr. Turchin. “These findings provide support for considering increased monitoring, more aggressive treatment of infections, and transitioning to a more intensive care setting for diabetic patients who have developed hypoglycemia in the general ward.”

The study was funded by grants from the Diabetes Action Research and Education Foundation and the National Library of Medicine.

Novel Non-Surgical Therapy Dramatically Increases Weight Loss in Obese Patients; Results from Pilot Clinical Study Presented at ASMBS

2009-06-26T15:30:17Z

June 26, 2009 (Press Release) - GI Dynamics, a leader in non-surgical treatments for type 2 diabetes and obesity, today announced results from a pilot clinical study which demonstrated the substantially enhanced weight loss effects of combining the company’s EndoBarrier Gastrointestinal Liner with a new EndoBarrier Flow Restrictor. The EndoBarrier Flow Restrictor provides an adjustable restriction at the outlet of the stomach and is designed to delay gastric emptying, an additional mechanism which adds to the therapeutic effects of the liner. The results were presented today at the 26th annual meeting of the American Society for Metabolic and Bariatric Surgery (ASMBS).

In this initial, single-center study of 10 morbidly obese people (body mass index between 35.8 and 47.8), participants achieved the following results over a twelve-week period during which the device was implanted (median values reported):

· Percent Excess Weight Loss (%EWL): 39.6%

· Weight Loss: 36.7 pounds (16.7 kilograms)

· Percent Total Body Weight Loss (%TBWL): 15.4%

All 10 patients completed the 12-week study. The most common side effects included mild to moderate abdominal pain, nausea and vomiting.

“These results are unparalleled for a non-surgical treatment for obesity,” stated Alex Escalona, M.D., Department of Digestive Surgery, Pontificia Universidad Católica de Chile, Santiago, Chile and lead investigator for the pilot study. “Like the United States, Chile is struggling with a growing epidemic of obesity and related metabolic disorders and life-threatening conditions. Traditionally, non-surgical treatment approaches have proven insufficient for the morbidly obese, but these data suggest we may have an effective new option to offer these patients. Based on the excellent results I observed in this pilot study, I believe the combination device may offer hope for patients battling significant weight-loss needs and associated co-morbidities, and clearly deserves further study in longer-term, controlled clinical trials.”

Clinical trials involving more than 250 patients have demonstrated the dramatic weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner. These latest data suggest that the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor could enhance the effectiveness of the liner by nearly doubling the amount of weight-loss achieved by using the liner alone. These clinical data are consistent with recently reported pre-clinical data assessing the combination of devices in a porcine model. The preclinical data were featured at the Society of American Gastrointestinal and Endoscopic Surgeons 2009 Annual Meeting in April.

“We are very pleased with the results seen in this pilot study and the increased effect on weight loss achieved by the combination of the EndoBarrier Gastrointestinal Liner with the EndoBarrier Flow Restrictor,” said Stuart A. Randle, chief executive officer of GI Dynamics. “We believe that the combination of these devices impacts weight loss through distinct mechanisms of action and may truly represent a breakthrough in non-surgical treatment of type 2 diabetes and obesity. GI Dynamics is conducting ongoing clinical studies investigating the synergistic effects of the combined devices. Our platform is well positioned to deliver a portfolio of devices that will allow physicians to choose the most appropriate non-surgical therapy for each patient’s individual weight loss goals and glycemic control needs.”

GI Dynamics is defining a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics. Non-surgical therapeutics are designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time. Unlike traditional pharmaceutical approaches, non-surgical therapeutics remove the burden of dose regimen compliance from the patient. Additionally, non-surgical therapeutics hold the potential to improve the patient’s overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.

Dietary Fat Linked to Pancreatic Cancer

2009-06-26T15:15:27Z

Juner 26, 2009 (EurekAlert) - High intake of dietary fats from red meat and dairy products was associated with an increased risk of pancreatic cancer, according to a new study published online June 26 in the Journal of the National Cancer Institute.

This study was undertaken because research relating fat intake to pancreatic cancer was inconclusive.

To examine the association, Rachael Z. Stolzenberg-Solomon, Ph.D., of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute in Bethesda, Md., and colleagues analyzed a cohort of over 500,000 people from the National Institutes of Health – AARP Diet and Health Study. Participants completed a food frequency questionnaire in 1995 and 1996 and were followed prospectively for an average of 6 years to track a variety of health outcomes, including pancreatic cancer.

Men and women who consumed high amounts of total fats had 53% and 23% higher relative rates of pancreatic cancer, respectively, compared with men and women who had the lowest fat consumption. Participants who consumed high amounts of saturated fats had 36% higher relative rates of pancreatic cancer compared with those who consumed low amounts.

"[W]e observed positive associations between pancreatic cancer and intakes of total, saturated, and monounsaturated fat overall, particularly from red meat and dairy food sources. We did not observe any consistent association with polyunsaturated or fat from plant food sources," the authors write. "Altogether, these results suggest a role for animal fat in pancreatic carcinogenesis."

In an accompanying editorial, Brian M. Wolpin, M.D., MPH, of the Dana Farber Cancer Institute in Boston and Meir J. Stampfer, M.D., DrPH, of the Harvard School of Public Health, call the study well-performed and a good addition to the understanding of pancreatic cancer.

They do note, however, that there is insufficient epidemiological and laboratory evidence to confirm the importance of animal fats or even that meat is the important factor, as opposed to other dietary or lifestyle preferences associated with meat consumption.

"[W]ith further investigation, this work has the potential to provide interesting clues to the mechanisms underlying pancreatic tumorigenesis," the editorialists write.