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OPTIMIZING RECOVERY AND PRESERVATION OF ENDOGENOUS INSULIN SECRETION (RISE)

Principal Investigator:  Sharon Edelstein, ScM
Homepage:  http://risestudy.org

 
The Biostatistics Center serves as the research and data Coordinating Center (CoC) for the Optimizing Recovery and Preservation of Endogenous insulin Secretion (RISE) studies. The consortium is a collaboration between seven clinical centers and the CoC. RISE consists of three feasibility studies in patients with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of islet function that will be sustained after treatment. One study in adults is a 4-arm, partially blind clinical trial comparing metformin alone, the combination metformin and the incretin mimetic liraglutide, insulin glargine for 3 months followed by metformin, and placebo. A parallel study in children 10-17 years is a 2-arm unblinded clinical trial comparing metformin alone to insulin glargine for 3 months followed by metformin. The third trial in adults is comparing lap-band surgery to metformin along. The clinical questions that RISE studies will address are: Does early, aggressive glucose lowering improve beta-cell function following 12 months of active treatment be maintained for 3 months and longer following the withdrawal of therapy. The studies will also ascertain whether simpler measures of beta-cell function are sufficiently well correlated with the more sophisticated assessments to validate their use in large interventional clinical trials. The RISE Coordinating Center is funded as a subaward from the University of Washington, under NIDDK prime award 1 U01 DK094406-01, Sept. 2011-June 2016.)