Metabolically Normal and Metabolically Abnormal Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in skeletal muscle insulin sensitivity
研究概览
简要总结
The purpose of this study is to learn more about why some obese persons are resistant to developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease), while others are prone to developing these conditions. We will do this by studying obese persons before and after a 5% body weight gain.
Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to increase their current body weight by 5%. Each will then be asked to maintain this weight increase for 3 weeks. We will monitor subjects throughout this time period with weekly medical evaluations. At the completion of the study, we will provide each subject with a 6-month weight loss program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese subjects (BMI 30.0 - 39.9 kg/m2)
- •Sedentary subjects (exercise less than 1 hr/wk)
排除标准
- •Pregnant or lactating women
- •Michigan Alcohol Screening Test score ≥4
- •Active or previous history of liver disease
- •Active or previous history of diabetes
- •history of alcohol abuse, or currently consuming ≥20 g alcohol/day
- •Severe hypertriglyceridemia (>300 mg/dL)
- •Smoke tobacco
- •Take medication that might confound the study results
结局指标
主要结局
Change in skeletal muscle insulin sensitivity
时间窗: an average of three months, from baseline to 5% weight gain
Change in hepatic insulin sensitivity
时间窗: an average of three months, from baseline to 5% weight gain
Change in de novo lipogenesis
时间窗: an average of three months, from baseline to 5% weight gain
Change in Intrahepatic Triglyceride
时间窗: an average of three months, from baseline to 5% weight gain
Change in VLDL kinetics
时间窗: an average of three months, from baseline to 5% weight gain
次要结局
- Change in adipose tissue insulin sensitivity(an average of three months, from baseline to 5% weight gain)
- Change in CD36 concentration in skeletal muscle(an average of three months, from baseline to 5% weight gain)
- Change in cell proliferation (growth) rates in the colon(an average of three months, from baseline to 5% weight gain)
- change in CD36 concentration in adipose tissue(an average of three months, from baseline to 5% weight gain)