NCT00346970已完成4 期
Randomized Clinical Trial to Study the Effect of Extended Release Niacin on Endothelial Function, Oxidative Stress and Endothelial Progenitor Cells in Patients With the Metabolic Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Antioxidative Properties of Endothelial Progenitor Cells
研究概览
简要总结
The aim of the present study is to characterize novel mechanisms whereby HDL may exert potent vasculoprotective effects independent of reverse cholesterol transport, in particular the effect of HDL on the regulation of the vascular NAD(P)H oxidase enzyme system, a major vascular source of superoxide, known to be important for endothelial dysfunction. In addition, the present study will characterize the effect of HDL on endothelial progenitor cell (EPC) mobilization, nitric oxide production and in vivo regenerative capacity.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Statin treatment for at least 3 weeks
- •Reduced HDL: < 40 mg/dL (1.03 mmol/L) in men or < 50 mg/dL (1.29 mmol/L) in women
- •Plus TWO of the following (thereby defining the patients to have metabolic syndrome (Grundy et al.; Circulation 2005)):
- •Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women
- •Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L
- •Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg diastolic blood pressure or anti-hypertensive treatment
- •Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated fasting glucose
排除标准
- •Hypersensitivity to niacin
- •Active liver disease or impaired liver function
- •Persistent elevation of transaminases
- •Cholestasis
- •Gastric ulcer
- •Acute coronary syndrome
- •Pregnancy, lactation
- •Active infections
- •Untreated concomitant diseases
- •Renal insufficiency or renal failure
- •Hypothyreosis
- •Alcoholism
- •Myopathies
- •Muscle pain under therapy with fibrates or statins
- •Hereditary muscle diseases in family history
研究组 & 干预措施
1
Experimental
Extended-release Niacin
干预措施: Extended-Release Niacin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Antioxidative Properties of Endothelial Progenitor Cells
时间窗: 3 months
FDD
时间窗: 3 months
次要结局
- High Density Lipoprotein (HDL) Elevation(3 months)
研究者
研究点 (1)
Loading locations...
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