Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) Clinical Centers (Collaborative U01 Clinical Trial Required)

The purpose of this Limited Competition Funding Opportunity Announcement (FOA) is to continue follow-up of the Diabetes Prevention Program Outcomes Study (DPPOS) cohort through a collaborative cooperative agreement. The Diabetes Prevention Program (DPP) was a multi-center controlled clinical trial examining the efficacy of treatments to prevent or delay the development of type 2 diabetes in a population at high risk. The DPP demonstrated that either weight loss through lifestyle change or the drug metformin could reduce the development of type 2 diabetes by 58% and 31%, respectively, compared with placebo. Following the end of DPP, the DPP cohort was enrolled in the DPPOS to determine the long-term effects of the DPP interventions on further diabetes development and microvascular complications. The current funding period is focused on examining the effectiveness of early metformin treatment on the development of cancer and cardiovascular disease. The DPPOS study population has aged, and there is an opportunity to study the heterogeneity in chronic disease development and progression in this well-characterized, diverse study population. The primary purpose of this FOA is to support the existing DPPOS clinical centers to maintain follow-up of the DPPOS cohort, through a uniform protocol,to continue to explore contributors to the development of multiple chronic conditions, including, but not limited to, cognitive impairment, cancer, and diabetes vascular complications, and to evaluate whether the DPP interventions have any preventive effect on the development of these chronic conditions. RFA-DK-20-502 will support continuation of the DPPOS Biostatistics Research Center.