Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)
研究概览
简要总结
This study tests the hypothesis that exercise training can confer additional benefit to patients in weight-loss programs in the form of improvements in either metabolic or vascular parameters or both. Patients will be randomized to either diet plus conventional physical activity or diet plus a planned exercise training. The interventions will be carried out until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end, all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin, c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and abdominal visceral fat (CT-scan). Both groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI> 30 and <40
排除标准
- •Diabetes mellitus
- •Active endocrine disease
- •Active heart disease
- •Active smoking
- •Medical contra-indications for exercise
- •Using anti-obesity drugs
研究组 & 干预措施
Lifestyle counseling
Patients will receive dietary counseling and a general advice on physical activity
干预措施: General lifestyle, diet and physical activity counselling (Behavioral)
Exercise training
patients will receive dietary counseling and will be enrolled in supervised exercise training
干预措施: Exercise training (Behavioral)
结局指标
主要结局
Reduction in homeostasis model assessment of insulin resistance (HOMA-IR)
时间窗: 6 months
Change in lipid profile
时间窗: 6 months
Reduction in abdominal (visceral) fat
时间窗: 6 months
Change in vascular reactivity
时间窗: 6 months
次要结局
- C-reactive protein(6 months)
- Fibrinogen(6 months)
- vonWillebrand factor(6 months)
- Waist circumference(6 months)