NCT00350064Unknown不适用
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Change in Abdominal Visceral Fat
研究概览
简要总结
The purpose of this study is to determine if sixteen weeks of high intensity physical training is more effective than sixteen weeks of low intensity physical training in reducing abdominal fat and lowering risk factors associated with the metabolic syndrome. Another aim of this study is to determine if high intensity physical training improves cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers must have meet the definition of the metabolic syndrome (based on IDF consensus statement).
- •Screening biochemical tests of liver, kidney, hematologic, metabolic (below) and thyroid function must be normal.
- •The volunteer must be willing to:
- •visit the outpatient GCRC or clinic once monthly for 16 weeks of intervention,
- •participate in supervised exercise training (if assigned) and
- •enter the inpatient GCRC for 2-3 days of more intensive studies at baseline and after 16 weeks of intervention. The subject must provide voluntary and fully informed written consent.
排除标准
- •Type 1 diabetes,
- •drug or alcohol abuse,
- •psychosis,
- •severe or untreated depression,
- •dementia, polycythemia (hematocrit > 55%),
- •clinically symptomatic coronary artery,
- •pulmonary or orthopedic disease (which would disallow exercise training),
- •history of vascular or peripheral nerve trauma,
- •lymph node dissection,
- •anemia, uncontrolled hypertension (> 160/105 untreated or > 145/95 treated),
- •allergic to octafluoropropane, or nitroglycerine,
- •weight loss or gain of 2 kg or more within the preceding 10 days,
- •investigational drug use within five biological half-lives,
- •treatment with ACE inhibitors or ARBs, thiazolindiones,
- •1st or 2nd generation anti-psychotics insulin, or Viagra,
- •unwillingness to provide written informed voluntary consent,
- •pregnant, breast feeding or use hormonal birth control.
结局指标
主要结局
Change in Abdominal Visceral Fat
时间窗: before and after 16 weeks
次要结局
- Adhesion Molecules(before and after 16 weeks)
- VO2peak(before and after 16 weeks)
- % Body Fat(before and after 16 weeks)
- Insulin(before and after 16 weeks)
- FFA(before and after 16 weeks)
- Glucose(before and after 16 weeks)
- Hba1c(before and after 16 weeks)
- Cholesterol(before and after 16 weeks)
- CRP(before and after 16 weeks)
- IL6(before and after 16 weeks)
- TNF(before and after 16 weeks)
- Homocysteine(before and after 16 weeks)
- Adiponectin(before and after 16 weeks)
- Endothelial Function(before and after 16 weeks)
研究者
研究点 (2)
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