Update on Salicylate Clinical Trials at Joslin Diabetes Center
Steven E. Shoelson, M.D., Ph.D., Helen and Morton Adler Chair and Head of the Section on Cellular and Molecular Physiology at Joslin, and Professor of Medicine at Harvard Medicine School, has performed a series of elegant studies to demonstrate an important role in animals for inflammation mediated by the IKK/NFkB pathway in the pathogenesis of insulin resistance. This pathway is turned on in fat and liver by Western diet and weight gain and this leads to type 2 diabetes. Dr. Shoelson and his colleagues at Joslin in Boston have been interested in determining whether this pathway is similarly involved in people, and whether they may be able to target this pathway using pharmacologic agents (drugs) to treat diabetes, or perhaps even to prevent the development of disease in people at risk. The IKK/NFkB pathway is not directly targeted by drugs currently available to treat diabetes, so these studies may lead to novel therapies.
For several years Joslin Diabetes Center has conducted a small clinical trial headed by Allison Goldfine, M.D., and funded by the National Institutes of Health. Dr. Goldfine is an Investigator in the Joslin Section on Cellular and Molecular Physiology Assistant Director of the Joslin Clinical Research Section, and Assistant Professor of Medicine at Harvard Medical School.
The Joslin investigators are particularly interested in the clinical use of a class of drugs called salicylates. The best-known drug in this class is aspirin. However, the long-term use of high doses of aspirin can lead to bleeding complications. Instead, the researchers favor the use of an alternative drug called salsalate, which is very safe and currently used in people to treat arthritis and related inflammatory conditions.
To date more than 20 patients with type 2 diabetes have participated in Joslin’s clinical trials looking at the use of aspirin-like drugs to treat diabetes. In the study the participants take a high dose of a salsalate for two weeks. The results are encouraging, showing that salsalate improves insulin sensitivity and lowers blood glucose and lipids in people when given for only two weeks.
“Preliminary data from the study looks good. We know the mechanism of action and we see beneficial effects. Importantly, the drug has been used in many thousands of patients previously for many years, so we know that it is safe. We are working with the National Institutes of Health to expand the study into a larger study that would be conducted over a longer period of time and involve more study participants,” said Dr. Shoelson.
“We are currently trying to determine if these effects will be sustained for longer intervals of time and the best dose to use,” added Dr. Goldfine. “We also are trying to determine if the drug may help in people who do not yet have diabetes, but are overweight and at risk to develop disease. Our future plans are to study the drug in larger clinical trials.”
If you are interested in this research study and are between the ages of 18-60 with type 2 diabetes you would be asked to make four visits to Joslin Diabetes Center in Boston over 4-5 weeks and to take either an FDA-approved medication or placebo. Those wanting more information about the study can contact Robert Silver, M.D., at 617-264-2731, or by e-mail at: Robert.Silver@joslin.harvard.edu. (CHS#00-01)
If you are interested in learning about this or other clinical research studies being conducted at Joslin Diabetes Center, please visit Joslin’s Web site at the link http://www.joslinresearch.org/PINET/ClinicalDetail.asp?clinicalSectionID=3 or call toll-free 1-800-JOSLIN-1.
Updated January 31, 2005
