Trials for adults and youth compare treatments in newly diagnosed people
For Immediate Release: Wednesday, May 22, 2013
The National Institutes of Health is looking for volunteers to take part in one of three clinical trials to improve and preserve the production of insulin in people with prediabetes or recently diagnosed type 2
diabetes. The project is called the Restoring Insulin Secretion study (RISE).
Participants must have prediabetes or have been diagnosed with type 2 diabetes within the past year. Two trials will examine adults; the other will look at youth. Type 2 diabetes is increasing in adults and young people. In people over age 65, combined prevalence of prediabetes and diabetes is greater than 50 percent. Although type 2 diabetes had been rare in youth, the disease is becoming more common with the rise of childhood obesity. In 2012, the NIDDK-funded
Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY)
study found that the disease may worsen faster and be harder to treat in young people than in adults.
The studies will be conducted for five years. They will use common assessments, so results can be compared head to head. Treatments with the most promising results may then be tested in larger, definitive trials.
When type 2 diabetes is diagnosed, the body is usually producing some insulin — a hormone that helps glucose, or sugar, get from food into cells — but it cannot use the insulin effectively, a condition called insulin resistance. Over time, insulin production decreases. Glucose, the body’s main source of fuel, builds up in the blood and the body cannot make efficient use of glucose, often leading people with type 2 diabetes to need to take insulin injections. Prediabetes means the amount of glucose in the blood is higher than normal but not high enough to be called diabetes.
“By examining the effects of different treatments in people with prediabetes and early type 2 diabetes, who still produce substantial amounts of insulin, we hope to learn how to reverse or slow the progressive loss of insulin production that comes with increasing duration of the disease, so that these people can stay healthier longer,” said Peter Savage, M.D., a project scientist and a senior advisor for clinical research at the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases.
One adult trial will compare weight loss using a gastric band that narrows food’s access to the stomach to standard advice and metformin, the most common drug used to treat early diabetes. The trial aims to enroll 88 people at the University of Southern California, Los Angeles. (To enroll, see ClinicalTrials.gov: NCT01763346.)
A second adult trial will compare a placebo to three drug regimens, all approved to treat type 2 diabetes by the U.S. Food and Drug Administration: metformin alone; metformin plus liraglutide, a drug that increases the amount of insulin released in response to nutrients; and glargine, a long-acting insulin that would be used for three months before switching to metformin. The trial aims to enroll 255 people at the VA Puget Sound Health Care System and University of Washington, both in Seattle; Indiana University, Indianapolis; and the University of Chicago (ClinicalTrials.gov: NCT01779362).
The trial in youth, aiming to enroll 90 people aged 10-19 years old, will compare metformin alone to glargine. Glargine would be used for three months before switching to metformin. The trial will be conducted at the Children’s Hospital Colorado, University of Colorado, both in Aurora; Children’s Hospital of Pittsburgh; Yale University, New Haven, Conn.; and Indiana University, Indianapolis (ClinicalTrials.gov: NCT01779375).
“Along with comparing treatments in adults, the RISE studies will enable us to make direct comparisons between young people and adults with prediabetes and early type 2 diabetes in terms of how their bodies respond to treatments,” said NIDDK Director Griffin P. Rodgers, M.D. “If successful, RISE studies will help to develop treatments that will slow the progression of prediabetes and diabetes.”
RISE is supported under NIH grants U01DK94430, U01DK94431, U01DK94406, U01DK94438 and U01DK94467.
The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see http://www.niddk.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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