The Effects of Pentoxifylline on PAI-1 in an Obese Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in PAI-1 Level
研究概览
简要总结
PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects.
详细描述
Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pentoxifylline
Patients receive Pentoxifylline 400 mg po TID for 8 weeks.
干预措施: Pentoxifylline (Drug)
Placebo
Patients take a placebo TID for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in PAI-1 Level
时间窗: Baseline and 8 weeks
次要结局
- Change in CRP Level(Baseline and 8 weeks)
- Change in TNF-alpha Level(Baseline and 8 weeks)
- Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.(Baseline and 8 weeks)
研究者
James Muldowney
Assistant Professor
Vanderbilt University Medical Center