TREATMENT OPTIONS FOR TYPE 2 DIABETES IN ADOLESCENTS AND YOUTH (TODAY)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an NIH/NIDDK-sponsored, multicenter, randomized, controlled, clinical trial designed to evaluate the safety and efficacy of three treatment regimens for type 2 diabetes mellitus (T2DM) in children and youth. This protocol is developed by the STOPP-T2D (Studies to Treat Or Prevent Pediatric Type 2 Diabetes) study group, and will be implemented at 13 clinical centers. The three treatment regimens being compared are: metformin alone, metformin plus rosiglitazone and metformin plus an intensive lifestyle intervention aimed at 7-10% weight loss. Medication arms of the protocol are double-blinded and primary outcomes are masked with unmasking as necessary for clinical care and safety. The primary outcome is the time to "treatment failure" (defined as HbA1c8% for 6 months or an inability to avoid metabolic decompensation without insulin). Secondary outcomes include: level of glycemic control; medication safety; insulin sensitivity and secretion; body composition; nutrition, physical activity and physical fitness; cardiovascular risk factors; microvascular complications; quality of life; and cost effectiveness. Subjects 10-17 years old with T2DM for 2 years will be recruited over a 3-1/2 year period and followed for 2-6 years.