Ann Arbor, Mich. - Joslin Diabetes Center scientists will collaborate with the University of Michigan Comprehensive Diabetes Center to take groundbreaking research on the role of inflammation in type 2 diabetes to a new level.
A national clinical trial will investigate whether salsalate, an anti-inflammatory drug used for years to manage arthritis pain, can reduce blood glucose levels in people with type 2 diabetes. If successful, the trial could one day lead to an inexpensive way to treat the most common form of diabetes.
About 560 adults with poorly controlled blood glucose levels are being sought to participate for one year in the clinical research study, referred to as Targeting Inflammation with Salsalate in type 2 Diabetes (TINSAL-T2D).
Joslin researchers showed salsalate was effective at lowering blood sugars when given for three months, leading to the start of this larger trial of longer duration. The trial, led by Joslin, is being conducted there, the University of Michigan and 20 other medical institutions across the country.
"These are very important studies aimed to test whether reducing inflammation can actually be used to treat diabetes," says principal investigator Steven E. Shoelson, M.D., Ph.D., associate director of research at Joslin and professor of medicine at Harvard Medical School.
"Given what we are learning about how type 2 diabetes develops, we think this might be getting at an underlying cause. We hope the study shows that targeting inflammation is a safe and inexpensive way to treat type 2 diabetes," he says.
Type 2 diabetes is a disorder in which muscle and fat cells do not use insulin properly. Nearly 24 million Americans have diabetes, and type 2 diabetes accounts for 90 percent to 95 percent of diagnosed cases.
It is closely linked to obesity and its complications increase the risk for cardiovascular disease, blindness, kidney disease and amputations.
"Sedentary lifestyle and western diet have been associated with obesity and diabetes," says Rodica Pop-Busui, M.D., Ph.D
., assistant professor of metabolism, endocrinology and diabetes at U-M Medical School and principal investigator at the U-M diabetes center.
"The study medication, salsalate, which is chemically similar to aspirin but has fewer side effects, has been used for more than 40 years in people to treat pain associated with arthritis. Recent studies in people shows that salsalate also lowers blood glucose, but further testing on long term efficacy and safety specifically in patients with diabetes needs to be done."
The study is being funded by the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.
"The outcome of this study has the potential for significant public health benefit," said Myrlene Staten, M.D., NIDDK's senior advisor for diabetes translational research. "If salsalate improves the control of type 2 diabetes, we would have an inexpensive addition to our arsenal of drug options."
For the TINSAL-T2D study, the researchers are seeking adults ages 18 to 75 whose glucose levels are not in good control and who don't take insulin. Participants must be using no medication or be taking only one or two oral medications, among other criteria. Most participants can expect their involvement to last about one year.
Those volunteering to participate in the TINSAL-T2D study will undergo a variety of tests to determine if they are eligible. Participants selected for the study may receive either the study drug or a placebo. A placebo is an inactive pill that likes like the study drug, but the placebo does not contain active medication.
For more information about the study at the University of Michigan, contact Pop-Busui or Cynthia Plunkett, R.N., clinical study coordinator, at (734) 936-8065. Detailed sign-up information can be found by visiting Engage, http://www.umclinicalstudies.org/
, the gateway for clinical trials at U-M.
Michigan Comprehensive Diabetes Center
Michigan Institute for Clinical and Health Research