A clinical trial at the Veterans Affairs Puget Sound Health Care System and the University of Washington will address new approaches to prevent the development of type 2 diabetes or slow its progression. Participants will be treated with medications normally used for people who have had diabetes for at least one year. The study will enroll individuals who have prediabetes or have been recently diagnosed with diabetes, but who are not taking medications to treat the condition.
The Restoring Insulin Secretion, or RISE, Study will examine the effects of three such medication regimens. Each will be administered for 12 months. The three regimens are: liraglutide plus metformin for 12 months; insulin for 3 months followed by metformin for 9 months; and metformin alone for 12 months. The expectation is that the use of these medications before diabetes has developed will preserve or enhance the body’s ability to produce insulin, the hormone that is crucial to maintain normal blood sugar levels.
The RISE study is a nationwide program looking at the effects of various treatments to preserve insulin secretion and thereby prevent the development of diabetes or its progression early in the disease. The UW and VA diabetes research group in Seattle is one of three recruiting adult patients for the medication trial, along with the University of Chicago and Indiana University in Indianapolis.
Dr. Steven Kahn, professor of medicine, Division of Metabolism, Endocrinology and Nutrition, at the University of Washington, leads the Seattle clinical trial and is also chairs the national study.
“We hope to identify people who are at high risk of developing diabetes as they have mild elevations in their blood glucose as well as individuals who have had diabetes for less than a year and have not required medications,” Kahn said.
“The purpose of the study,” he explained, “is to determine whether aggressively treating such patients with medications used in diabetes can slow the disease process and prevent the loss of the ability of the pancreas to make and release insulin.”
The study, sponsored by the National Institutes of Health, is currently recruiting patients. To be eligible, patients must be between 20 and 65 years old, have prediabetes or self-reported type 2 diabetes for less than one year, and must not have taken any medications to treat diabetes in the past. Participants also must be considered overweight or obese. The investigators aim to enroll 85 patients who will participate in the trial for 21 months.
More details are available at the National Institute of Health’s ClinicalTrials.gov website, identifier: NCT01779362.
To participate in the RISE Study, interested individuals can call 206-764-2768.