Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- ApoB transport rate
研究概览
简要总结
The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.
详细描述
The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD). Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated. We therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Any three of the following:
- •Waist circumference > 102 cm
- •Triglycerides > 150 mg/dL
- •HDL-cholesterol < 40 mg/dL
- •Blood glucose > 110 mhg/dL
- •Blood pressures > 130/85 mmHg
排除标准
- •Triglycerides > 500 mg/dL
- •Diabetes mellitus
- •Consumption of > 30 g alcohol/day
- •Use of agents affecting lipid metabolism
- •APOE2/E2 genotype
- •Creatinemia (> 120 umol/L)
- •Hypothyroidism
- •Abnormal liver and muscle enzymes
研究组 & 干预措施
1
placebo group
干预措施: placebo pill (Drug)
2
GW501516, 2.5mg
干预措施: GW501516 (Drug)
结局指标
主要结局
ApoB transport rate
时间窗: 5 weeks
次要结局
- ApoA and C-III transport rate(5 weeks)