CLINICAL TRIAL: INTENSITIES OF AEROBIC EXERCISE VS ROSIGLITAZONE ON INSULIN

临床试验：有氧运动强度与罗格列酮对胰岛素的影响

• 批准号: 7960754
• 负责人: Stanley Hsia
• 金额: $ 0.16万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2009-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7960754
• 关键词: Adherence; Aerobic; Aerobic Exercise; Behavioral; Body Weight decreased; C-reactive protein; Cholesterol; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Counseling; Disease; Education; Educational Background; Exercise; Foundations; Funding; Grant; Health; Hispanics; Indirect Calorimetry; Institution; Insulin; Insulin Resistance; Low income; Measurement; Measures; Metabolic syndrome; Modeling; Obesity; Outcome; Outcome Measure; Overweight; Participant; Phase; Physical therapy exercises; Protocols documentation; Quality of life; Randomized; Research; Research Infrastructure; Research Personnel; Resources; Source; Stretching; Syndrome; Thick; Time; Training; United States National Institutes of Health; base; behavior measurement; career development; ethnic minority population; follow-up; high risk; indexing; insulin sensitivity; intima media; programs; rosiglitazone

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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 胰岛素抵抗综合征或代谢综合征是一个普遍的健康问题，特别是对西班牙裔少数民族来说；这种综合征的所有组成部分都可以通过锻炼来帮助。这项拟议的研究是一项随机的平行分组研究，将根据国家胆固醇教育计划(NCEP)的定义，比较中等强度(30%VO2Reserve)有氧计划、中等强度(60%VO2Reserve)有氧计划(基于间接量热法计算)和对照(伸展)运动计划，在六个月的监督训练期间，运动时间从20分钟到60分钟，每周三到五次，对代谢综合征的组成部分障碍进行比较。参与者将是超重或轻度肥胖、低收入和低教育水平的少数族裔，他们的六个月训练期之后将有六个月的无人监督的跟踪期，在此期间将评估自愿参加锻炼的情况。结果变量将包括胰岛素敏感性的直接测量(根据瘦体重进行校正)，以及基于静态模型的胰岛素敏感性估计，代谢综合征定义成分紊乱的特征，C反应蛋白，颈动脉内膜中层厚度测量，以及行为和生活质量指数。饮食咨询的目标是在六个月的监督锻炼期间减肥10%，受试者将被要求避免所有其他同时进行的锻炼计划。结果将使用意向治疗方法和按方案进行分析。将分析在监督培训期间的组内变化和组间差异，以及对选定结果变量的系列测量，这些测量将分析所需的培训时间，以观察每个变量自基线以来的重大变化。在非监督阶段结束时对结果变量的后续测量将与基线和监督阶段结束时的值进行比较。监督训练结束时的行为预测指标将通过非监督随访期与坚持自我发起的运动出勤率相关，并通过后续阶段与选定结果变量的变化相关联。这项建议还将作为PI在低收入、低教育水平、高危少数民族人群中针对代谢综合征进行运动治疗的职业发展基础。