Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)
研究概览
简要总结
The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.
详细描述
PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c < 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.
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
- Double
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
- •type 2 diabetes mellitus
- •stable oral treatment with metfromin and/or sulfonylurea
- •age 20 - 80 years
- •angiographically confirmed atherosclerosis or hsCRP > 1 mg/l
排除标准
- •type 1 diabetes
- •HbA1c > 8.5 %
- •severe disease
- •acute coronary syndrome
- •contraindications to pioglitazone (heart failure etc.)
研究组 & 干预措施
Pioglitazone
干预措施: pioglitazone (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)
时间窗: 4 weeks
次要结局
- Metabolic control (HbA1c, Glucose)(4 weeks)
- Safety(4 weeks)