Treatment options for type 2 diabetes in adolescents and youth: a study of the comparative efficacy of metformin alone or in combination with rosiglitazone or lifestyle intervention in adolescents with type 2 diabetes.

摘要: Despite the increased prevalence of type 2 diabetes mellitus (T2DM) in pediatric population, there is limited information about relative effectiveness treatment approaches. This article describes rationale and design a National Institutes Health-sponsored multi-site, randomized, parallel group clinical trial designed to test hypothesis that aggressive reduction insulin resistance early course T2DM beneficial for prolongation glycemic control, as well improvement associated abnormalities risk factors. Specifically, compares with metformin two alternate approaches, one pharmacologic (combining rosiglitazone) combining an intensive lifestyle intervention program. The Treatment Options Type Diabetes Adolescents Youth (TODAY) study recruits 800 patients over 4-yr period follows them minimum yr maximum 6 yr. Patients are 10-17 age, within diagnosis at time randomization, lack evidence autoimmunity, have sustained C-peptide secretion. primary outcome loss defined hemoglobin A1c >8% consecutive months. Secondary outcomes include effect alternative treatments on secretion resistance, body composition, nutrition, physical activity fitness, cardiovascular monitoring, microvascular complications, quality life, depression, eating pathology, resource utilization. TODAY first large-scale, systematic youth. When successfully completed, this will provide critical new regarding natural history youth, benefits initiating these patients, efficacy delivering children T2DM.