NCT00994513已完成2 期
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Biomarkers of oxidative stress
研究概览
简要总结
The major objective of this study is to conduct a double-blind, placebo-controlled, randomized clinical trial to assess whether oral alpha lipoic acid supplementation will decrease cardiovascular disease and type 2 diabetes risk in obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Han ethnicity
- •BMI≥25kg/m2
- •Having at least one of the following risk factors: borderline hypertension (130mmHg≤SBP<140mmHg or 85mmHg≤DBP<90mmHg), dyslipidemia (fasting total cholesterol ≥240mg/dl or HDL-C<40mg/dl), or impaired fasting glucose (fasting glucose levels between 6.1 and 7.0mmol/L)
- •18-60 years old
- •Not on any antioxidant vitamin supplement
排除标准
- •Pregnancy, lactation or child-bearing age without birth control device
- •History of hypertension, diabetes, coronary heart disease(CHD), cancer or liver disease
- •Anything that would impede the subject from complying with the ALA treatment
- •History of psychiatric problems
结局指标
主要结局
Biomarkers of oxidative stress
时间窗: 2 months
Insulin sensitivity
时间窗: 2 months
Endothelial function
时间窗: 2 months
次要结局
- Inflammatory markers(2 months)
- Blood pressure(2 months)
- Fasting lipid profile(2 months)
- Pulse wave velocity(2 months)
研究者
研究点 (1)
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