NCT01133210已完成1 期
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- effect of Maraviroc on plasma triglyceride concentration
研究概览
简要总结
The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
详细描述
The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:
- Plasma triglyceride concentration
- Plasma HDL-cholesterol and LDL-cholesterol concentrations
- Plasma markers of cardiometabolic risk and inflammation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obese (body mass index (BMI) between 30 and 45.9)
- •increased plasma triglyceride concentrations (150-400 mg/dL)
排除标准
- •active or previous infection with hepatitis B or C
- •history of alcohol abuse
- •current alcohol consumption (>20g/day)
- •severe hypertriglyceridemia (>400 mg/dL)
- •active peptic ulcer disease
- •pregnant or lactating
- •take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.
研究组 & 干预措施
Maraviroc
Experimental
Subjects will receive 12 weeks of treatment with maraviroc (300 mg po bid).
干预措施: Maraviroc (Drug)
Placebo
Placebo Comparator
Subjects will receive 12 weeks of treatment with placebo
干预措施: placebo (Other)
结局指标
主要结局
effect of Maraviroc on plasma triglyceride concentration
时间窗: 12 weeks
We will compare pre and post-treatment serum triglyceride concentrations in subjects receiving a 12 week course of either Maraviroc or placebo.
次要结局
- Effect of Maraviroc on serum HDL concentration(12 weeks)
- Effect of Maraviroc on plasma markers of cardiometabolic risk and inflammation(12 weeks)
- effect of Maraviroc on serum LDL-cholesterol concentration(12 weeks)
研究者
研究点 (1)
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