Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Thiobarbituric acid reactive substance; high sensitive C-reactive protein
研究概览
简要总结
The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.
详细描述
The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypercholesterolemic patients
排除标准
- •Patients receiving lipid-lowering agents
- •Familial hypercholesterolemia
- •Renal disease
- •Diseases of liver, gallbladder and bile ducts
- •Pregnant women
结局指标
主要结局
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
时间窗: 12 weeks
次要结局
- Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;(12 weeks)
- Homeostasis model assessment for insulin resistance; adiponectin;(12 weeks)
- Soluble intercellular adhesion molecule-1(12 weeks)
