This application seeks funding to complete the current protocols being conducted by the Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) consortium under the U01 cooperative agreement mechanism since 2002. Funding is requested for an additional 4 years to: (1) complete the current protocols and database quality control, (2) initiate analysis and report of outcome data and methods, and (3) archive and transfer the data to the NIDDK central repositories. The studies target minority youth. The treatment study group of 15 clinical centers is conducting two protocols. (1) TODAY is a multi-center, 3-arm, prospective, randomized, partially-blinded clinical trial. The primary object is to evaluate the safety and efficacy of 3 treatments to maintain glycemic control. Subjects (N=629 to date) aged 10-17 were recruited over a 4-year period, randomized within 2 years of diagnosis of T2D, and will be followed for 2-6 years. Recruitment is scheduled to end September 1, 2008, final randomization and baseline data collection on February 28, 2009, and final follow-up on February 28, 2011. (2) The TODAY genetics study protocol will enroll an additional 2500 participants who were diagnosed with T2D prior to their 18th birthday. The primary objective is to collect blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes, as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Recruitment is expected to start in late summer 2008 and continue until February 28, 2011. The prevention study group is conducting the HEALTHY primary prevention trial in 42 middle schools. A series of pilot and feasibility studies helped to define and develop study objectives and intervention. The primary objective is to reduce risk factors, such as obesity, associated with the development of T2D in intervention compared to control schools. The intervention changes the nutrition and physical activity environment throughout the school and includes educational and promotional events. Over 6000 6th graders were measured at baseline (fall 2006);final data are collected at end of 8th grade (spring 2009).
The recent and precipitous rises in rates of type 2 diabetes (T2D) and in obesity (the primary risk factor for T2D) in the pediatric population have important ramifications for our health care system. Previous research of treatment and prevention of T2D targeted mainly adults. The STOPP-T2D consortium represents one of the first large-scale federally-funded efforts to conduct studies to further our knowledge and understanding of these problems and their solution in children and adolescents.
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