Initial results of the Restoring Insulin Secretion (RISE) Study will be reported on Monday, June 25, at the Scientific Sessions.
Early findings have not been released, but no one will be surprised to see findings that point to changes in the treatment of prediabetes and early-onset diabetes in adolescents, said Steven E. Kahn, MB, ChB, who chairs the RISE Consortium and is a Professor and the Leonard L. Wright and Marjorie C. Wright Chair at the University of Washington and VA Puget Sound Health Care System.
“This is the first time we are going to learn about, in a direct comparison, how similar and how different youth and adults with impaired glucose tolerance and new-onset type 2 diabetes are, and whether interventions that have worked in adults have any applicability to prevent or treat new-onset type 2 diabetes in youth,” Dr. Kahn said.
RISE is a combination of three intervention trials, two in adults and one in adolescents. Initial results from the adolescent trial will be reported during Monday’s symposium The Restoring Insulin Secretion (RISE) Study in Adults and Youth—Baseline Data and Results of the Pediatric Medication Study. The two adult trials will be completed in the next year and reported later this year and next.
The three intervention studies are essentially feasibility studies, Dr. Kahn said. The study populations are relatively small, but will determine if larger studies, or different studies, should be conducted to bolster type 2 diabetes prevention efforts.
The first half of the RISE symposium at the Scientific Sessions will explore similarities and differences between the pediatric and adult populations. All three presentations are based on extensive and sophisticated baseline assessments of insulin sensitivity, beta cell function, and cardiovascular risk factors in adolescents and adults who have either impaired glucose tolerance or new-onset type 2 diabetes. This is the largest direct, prospective comparison of the pathophysiology of prediabetes and new-onset type 2 diabetes between pediatric and adult populations, Dr. Kahn noted.
“This is highly relevant because the general feeling is that youth who are found to have impaired glucose tolerance and early onset type 2 diabetes have a more rapidly progressive disease compared to adults,” he said. “The thought is that there must be something different about the pediatric disease. RISE will help fill in that picture.”
In the second half of the symposium, researchers will discuss results of the intervention study performed in the pediatric cohort. Adolescents with impaired glucose tolerance and recent-onset type 2 diabetes were treated either with insulin glargine for three months followed by nine months of metformin, or metformin for 12 months. Both groups had a three-month washout period before a reassessment of insulin sensitivity, beta cell function, and cardiovascular risk.
Metformin is typically the first-line treatment in type 2 diabetes, Dr. Kahn noted. Metformin has also been shown to slow progression of insulin resistance and preserve beta cell function, at least in adults with impaired glucose tolerance and recent-onset type 2 diabetes.
Adult trials have also shown that intensive insulin therapy in new-onset type 2 diabetes can slow progression and preserve or restore beta cell function. In RISE, insulin dosages were titrated to a fasting glucose between 80 mg/dl and 90 mg/dl. The trial design included only three months of intensive insulin therapy because researchers did not believe that long-term insulin therapy is a practical alternative for most adolescents.
“The hope is that between the two arms we will find a slowing of the progression of disease,” Dr. Kahn said. “That’s what the study is meant to do, to determine if we can preserve beta cell function. We know these interventions work in adults but we don’t know about youth. Join us at Scientific Sessions and be among the first to find out.”