CLINICAL TRIAL: INTENSITIES OF AEROBIC EXERCISE VS ROSIGLITAZONE ON INSULIN

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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. The insulin resistance syndrome, or metabolic syndrome, is a prevalent health problem, especially for Hispanic ethnic minorities; all components of this syndrome may be helped by exercise. The proposed study is a randomized, parallel-group study that will compare a mild-intensity (30 percent VO2Reserve) aerobic program, a moderate-intensity (60 percent VO2Reserve) aerobic program (calculated based on indirect calorimetry), and a control (stretching) exercise program, progressing from 20 to 60 minutes and from three to five times weekly over a six-month period of supervised training, on the component disorders of the metabolic syndrome, according to the definition of the National Cholesterol Education Program (NCEP). Participants will be overweight or mildly obese, low-income and low-education level ethnic minorities whose six-month training period will be followed by an unsupervised six-month follow-up period during which self-initiated attendance at exercise sessions will be assessed. Outcome variables will include a direct measure of insulin sensitivity (corrected for lean body mass) along with insulin sensitivity estimates based on static models, features of the defining component disorders of the metabolic syndrome, C-reactive protein, carotid intima-media thickness measures, and behavioral and quality-of-life indices. Dietary counseling will target a 10 percent weight loss over the six-month period of supervised exercise, and subjects will be asked to refrain from all other concurrent exercise programs. Results will be analyzed using both intent-to-treat and per-protocol approaches. Within-group changes and between-group differences through the period of supervised training will be analyzed, along with serial measurements of selected outcome variables, which will be analyzed for the time of training required to observe a significant change in each variable from baseline. Follow-up measures of outcome variables at the end of the unsupervised phase will be compared with the values at baseline and the end of the supervised phase. Behavioral predictors at the end of supervised training will be correlated with adherence to self-initiated exercise attendance through the period of unsupervised follow-up and the changes in selected outcome variables through the follow-up phase. This proposal also will serve as a career development foundation for the PI in exercise therapy for the metabolic syndrome in a low-income and low-education level, high-risk ethnic minority population.