Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Flow-mediated Dilation
研究概览
简要总结
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.
详细描述
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 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
- •prehypertension or Stage 1 hypertension
排除标准
- •Type 1 diabetes
- •Stage 2 hypertension
- •recent MI, revascularization, CVA or TIA
研究组 & 干预措施
aliskiren 300 mg once daily for 12 weeks
aliskiren 300 mg daily
干预措施: aliskiren 300 mg once daily (Drug)
Sugar pill/ placebo
Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo
干预措施: Placebo/sugar pill (Drug)
结局指标
主要结局
Change in Flow-mediated Dilation
时间窗: Baseline to 3 months
Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
次要结局
- Mean Central Aortic Pressure at 3 Months(3 months after start of study)
研究者
David Calhoun
Professor
University of Alabama at Birmingham