The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Flow Mediated Vasodilation
研究概览
简要总结
This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.
详细描述
We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:
- •abdominal obesity
- •elevated fasting blood sugar (110 mg/dL< glucose < 126 mg/dL)
- •elevated fasting blood triglycerides (> 150 mg/dL)
- •hypertension (BP > 140/90 mm HG)
- •Normal cardiovascular examination
排除标准
- •Diabetes mellitus
- •Untreated hypercholesterolemia (LDL > 75th percentile for age)
- •Cigarette smoking within 1 year
- •Renal insufficiency (creatinine > 1.4 mg/dl)
- •Blood dyscrasia
- •Hepatic dysfunction (ALT > 2x normal)
- •Evident coronary/peripheral atherosclerosis
研究组 & 干预措施
Acipimox
Acipimox treatment QID for 7 days
干预措施: acipimox (Drug)
Placebo
Placebo treatment QID for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Flow Mediated Vasodilation
时间窗: After 7 days of each treatment.
Brachial artery response to a 5 minute blood pressure cuff-applied ischemic period
次要结局
未报告次要终点
研究者
Joshua A. Beckman, MD
Associate Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital