LIFESTYLE CHANGE AND MEDICATION IN DYSLIPIDEMIC YOUTH WITH OBESITY RELATED IN

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。肥胖胰岛素抵抗儿童伴有或不伴有2型糖尿病，其低密度脂蛋白胆固醇（LDL- c）有细微的病理升高。LDL-C水平升高与成人心血管疾病的终生风险增加有关。药物和生活方式的改变被用来降低成人的LDL-C。关于治疗性生活方式改变（TLC）与药物治疗在生理相似的儿童中的有效性的信息很少。假设：胰岛素抵抗儿童给予药物和生活方式干预会比单独生活方式干预有更低的LDL-C。研究对象为年龄在10-17岁、患有肥胖相关胰岛素抵抗或2型糖尿病且LDL-C低于115mg/dl的儿童。受试者将被分层为2型糖尿病或肥胖相关胰岛素抵抗，接受TLC教育，然后随机分为3个治疗组，进行6周的干预。在干预前后测量LDL-C。第一组给予TLC + 2安慰剂。2组接受TLC +辛伐他汀+ 1安慰剂。3组接受TLC +辛伐他汀+依折替米贝。我们认为LDL-C降低1.5 SD具有临床意义。我们估计每只手臂需要10名受试者才能达到0.05的α和0.20的β。总共需要60个科目。使用ANCOVA分析数据。

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.