Characterization of Vascular Effects of Candesartan and Pioglitazone.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Vascular reactivity
研究概览
简要总结
The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.
详细描述
The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18 - 40 years old
- •non-smoker
- •no additional medication
排除标准
- •any relevant disease
- •elevated liver enzymes
- •body weight different from Broca Norm > 20%
- •allergies
结局指标
主要结局
Vascular reactivity
次要结局
- Pulse wave velocity
- Changes in Angiotensin metabolites