Inflammation and Vascular Function in Atherosclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Flow-mediated, Endothelium-dependent Vasodilation
研究概览
简要总结
The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.
详细描述
To test the hypothesis that inhibition of I [kappa] B kinase [beta] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smoking adult subjects with known atherosclerosis
排除标准
- •Uncontrolled hypertension (> 140/90 mmHg)
- •Untreated hypercholesterolemia (LDL > 160 mg/dL)
- •Diabetes mellitus
- •Alanine Aminotransferase > 150
- •Creatinine > 1.4 mg/dL
- •Concommitant use of warfarin
研究组 & 干预措施
Salsalate first, then Placebo
In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion.
干预措施: salsalate (Drug)
Placebo first, then Salsalate
In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy in a double-blinded fashion.
干预措施: placebo (Drug)
结局指标
主要结局
Flow-mediated, Endothelium-dependent Vasodilation
时间窗: Upon completion of 4 weeks of salsalate and placebo treatment
Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.
次要结局
未报告次要终点
研究者
Joshua A. Beckman, MD
MD
Brigham and Women's Hospital