NCT00314561已完成4 期
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome: A Prospective, Randomized, Open-label, Crossover Trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
研究概览
简要总结
Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol < 40 mg/dl for men and < 50 mg/dl for women.
- •Age: 18 years and above
排除标准
- •Hypertensive patients with the use of ACE inhibitor or ARB
- •Hyperlipidemic patients with the use of statin or fenofibrate
- •Patients with any contraindications to the treatment of thiazolidinediones
- •Pregnant or lactating patients
- •Chronic alcohol or drug abuse
- •Hepatic dysfunction
- •Renal dysfunction
- •Heart failure (EF < 50%)
- •Expected life expectancy of < 1 year
结局指标
主要结局
The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
次要结局
- The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.
研究者
研究点 (1)
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