Normally, medications like insulin and metformin are reserved for patients who have been diagnosed with type 2 diabetes for at least one year. A clinical trial at the University of Chicago Medicine aims to find new ways of preventing type 2 diabetes or slow its progression by treating participants with these drugs before the disease develops. The trial will enroll individuals who are prediabetic or have been recently diagnosed with diabetes but are not taking drugs to treat the condition.
The Restoring Insulin Secretion, or RISE, Study will examine the effects of three such medications: liraglutide, metformin and insulin. 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 on insulin secretion. The University of Chicago is one of three sites recruiting adult patients for the medication trial, along with the VA Puget Sound Health Care System in Seattle and Indiana University.“The goal is to identify people who are at high risk for diabetes and then treat them for one year with medications to prevent the development of diabetes. We also want to try to determine if people who have had diabetes for less than one year might benefit from treatment with these medications. In both cases, the idea is to see if we can prevent loss or even restore insulin secretion,” said David Ehrmann, MD, professor of medicine at the University of Chicago Medicine and principal investigator on the trial. Eve Van Cauter, PhD, professor of medicine at the University of Chicago Medicine, is a co-investigator on the study.
The trial, 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. Patients also must be considered overweight or obese.
The investigators have applied for additional funding to add a sleep study to the screening procedures of the RISE trial. They hope to determine whether the presence of a sleep disorder, such as sleep apnea, may reduce the efficacy of drug treatment. 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. The studies conducted are funded by the NIH, Grants # U01-DK094431 and UL1-TR000430.
To participate in the RISE Study or for more information, contact 773-702-0011.
For more information on RISE from the NIH, visit nih.gov.