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 a multi-center trial designed to evaluate three treatment regimens for type 2 diabetes (T2DM) in children and youth. The primary objective is to compare the efficacy of the three treatment arms on time to treatment failure based on glycemic control. The secondary aims are to evaluate the safety and compare the effects of the three treatment regimens, to evaluate the influence of individual and family behaviors on treatment response, and to compare the relative cost effectiveness of the three treatment plans. The three treatment regimens are: 1) metformin alone, 2) metformin plus rosiglitazone, and 3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program (TLP). Treatment will be masked so that subjects and study team do not know who is taking rosiglitazone. The study recruits patients over a three-year period and follows patients for a minimum of two years (maximum of five years). Subjects will have blood tests, glucose tolerance tests, and assessments of nutrition, physical activity, physical fitness, cardiovascular risk factors, microvascular complications, quality of life and psychological status. All subjects will receive standard diabetes education. The study consists of three steps. Step 1, or the 'screening step', consists of one outpatient visit for history, medical examination, and blood and urine tests. Eligible subjects will proceed to Step 2, or the 'run in step.' Step 2 may last 2-6 months (8-12 outpatient visits) and consists of diabetes education, clinical examinations, blood sugar monitoring, adjusting diabetes medications, testing tolerance of metformin, measuring physical activity, and the involvement of the designated Family Support Person (FSP). Step 3, or the 'treatment step', involves randomization into one of the three treatment arms. All subjects will take 2 capsules 2 times a day and have a medical visit once every 2 months for the first year of the study. In subsequent years of the study, the visits are every 3 months. Visit types are classified as 'regular', 'big', and 'super' visits and the procedures for each are described in the protocol and consent form. Subjects will be followed for 2 to 5 years depending on when they were enrolled. Prior to enrollment of participants, two pilot subjects will complete a series of study procedures and assessments. The pilot subjects will be children who are not otherwise eligible for the study because they are greater than 17 years or have had a diagnosis of diabetes for greater than 2 years. The study will enroll a total of 750 subjects over 3 years with 45 subjects expected at this site. The GCRC is needed for the majority of the study visits.
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