LIFESTYLE CHANGE AND MEDICATION IN DYSLIPIDEMIC YOUTH WITH OBESITY RELATED IN

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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. Obese insulin resistant children with and without Type 2 diabetes have a subtle, but pathological increase in their LDL cholesterol (LDL-C). Increased levels of LDL-C are associated with an increased lifetime risk of cardiovascular disease in adults. Medication and lifestyle change are used to lower LDL-C in adult populations. Little information is available about the effectiveness of Therapeutic Lifestyle Change (TLC) vs. medication in children with similar physiology. Hypothesis: insulin resistant children given medication and lifestyle intervention will have a lower LDL-C than with lifestyle intervention alone. Children, age 10-17 years, with obesity related insulin resistance or type 2 diabetes mellitus and LDL-C > 115mg/dl will be recruited. Subjects will be stratified to type 2 diabetes mellitus or obesity related insulin resistance, receive TLC education, then randomized to 3 treatment arms for 6 weeks of intervention. LDL-C will be measured before and after interventions. Group one will receive TLC + 2 placebos. Group 2 will receive TLC + simvastatin+ 1 placebo. Group 3 will receive TLC + simvastatin + Ezetimibe. We believe 1.5 SD decrease in LDL-C is clinically significant. We estimate that we will need 10 subjects in each arm to achieve an alpha at 0.05 and beta at 0.20. A total of 60 subjects will be needed. Data will be analyzed using ANCOVA.