NCT00675740已完成4 期
Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
University of Leipzig0 个研究点目标入组 45 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- between-group difference in flow-mediated dilation of the brachial artery
研究概览
简要总结
The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •impaired fasting glucose or impaired glucose tolerance
- •angiographic evidence of coronary artery disease
排除标准
- •diabetes mellitus type I or II
- •preexisting antidiabetic medication
- •unstable angina
- •indication for coronary bypass surgery
- •significant left main disease
- •myocardial infarction within preceding 3 months
- •ejection fraction < 40%
- •significant heart valve disease
- •severe metabolic disorders
- •severe disorders in lipoprotein metabolism
- •thyroid disorders
- •alcohol or drug abuse
- •pregnancy
- •participation in another trial
研究组 & 干预措施
1
Experimental
干预措施: rosiglitazone (Drug)
2
Active Comparator
physical exercise
干预措施: physical exercise (Behavioral)
3
No Intervention
control
干预措施: control (Other)
结局指标
主要结局
between-group difference in flow-mediated dilation of the brachial artery
时间窗: 6 months
次要结局
- relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies(6 months)
研究者
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