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临床试验/NCT00929890
NCT00929890Unknown不适用

Effect of Weight Loss Through Dietary Energy Restriction With or Without Exercise on Vascular and Metabolic Parameters in Subjects With Obesity

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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