Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in Lgi3 level
研究概览
简要总结
Leucine-rich glioma inactivated 3(Lgi3) has been postulated to have a pro-inflammatory adipokine that inter-plays with other adipokines in adipogenesis and metabolic inflammation according to recent investigations. Thus, in this study, we sought to demonstrate that the treatment of statin can decrease Lgi3 level along with the decrease of the atherosclerosis to further evaluate the role of Lgi3 in atherosclerosis.
详细描述
Patients who assigned to the pitavastatin treatment first group will be given the pitavastatin 4 mg qd treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and life-style modification treatment for 12 weeks. Similarly, patients who assigned to the life-style modification treatment first group, will be treated with life-style modification treatment for 12 weeks after randomization, followed by wash-out period of 3 weeks and pitavastatin treatment for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80 years
- •Patients with intermediate or low cardiovascular risks needing the statin treatment
- •Patients with intermediate or low cardiovascular risks treating the statin treatment
排除标准
- •Patients without signed informed consent
- •Patients with myopathy
- •Pregnant women or women with potential childbearing
- •Patients with diabetes
- •Patients with established coronary artery disease
- •Patients with heart failure
- •Life expectancy less than 1 year
研究组 & 干预措施
Pitavastatin treatment
Treatment of pitavastatin 4 mg qd for 12 weeks
干预措施: Treatment of pitavastatin 4 mg qd for 12 weeks (Drug)
Life-style modification
干预措施: Life-style modification (Behavioral)
结局指标
主要结局
Changes in Lgi3 level
时间窗: At 12 weeks after intervention
次要结局
未报告次要终点