LIFESTYLE CHANGE AND MEDICATION IN DYSLIPIDEMIC YOUTH WITH OBESITY RELATED IN

与肥胖相关的血脂异常青少年的生活方式改变和药物治疗

• 批准号: 7375004
• 负责人: Siripoom V McKay
• 金额: $ 2.08万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375004
• 关键词: LIFESTYLE; CHANGE; MEDICATION; DYSLIPIDEMIC; YOUTH

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。肥胖的胰岛素抵抗儿童有和没有2型糖尿病有一个微妙的，但病理性的增加，他们的低密度脂蛋白胆固醇（LDL-C）。LDL-C水平升高与成人心血管疾病终生风险增加相关。药物和生活方式的改变用于降低成年人群的LDL-C。 关于治疗性生活方式改变（TLC）与药物治疗在具有相似生理学的儿童中的有效性的信息很少。假设：接受药物治疗和生活方式干预的胰岛素抵抗儿童的LDL-C低于仅接受生活方式干预的儿童。将招募年龄为10-17岁的患有肥胖相关胰岛素抵抗或2型糖尿病且LDL-C > 115 mg/dl的儿童。受试者将被分层为2型糖尿病或肥胖相关的胰岛素抵抗，接受TLC教育，然后随机分配至3个治疗组进行6周干预。将在干预前后测量LDL-C。第一组将接受TLC + 2安慰剂。第2组将接受TLC +辛伐他汀+ 1份安慰剂。第3组将接受TLC +辛伐他汀+依折麦布。我们认为LDL-C降低1.5 SD具有临床意义。我们估计每组需要10名受试者才能实现α = 0.05和β = 0.20。总共需要60名受试者。将使用ANCOVA分析数据。