The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Flow Mediated Vasodilation
研究概览
简要总结
The purpose of this research is to study and determine the effects of Aliskiren on blood vessels and blood flow. The primary hypothesis is that Aliskiren will increase endothelial function by 30% or more in comparison to the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Aliskiren
干预措施: Aliskiren (Drug)
结局指标
主要结局
Flow Mediated Vasodilation
时间窗: 12 Weeks post-randomization
Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.
Nitroglycerine Induced Vasodilation
时间窗: 12 Weeks post-randomization
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside
时间窗: 12 Weeks post-randomization
Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).
Nitroglycerin Induced Dilation
时间窗: Baseline
Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.
次要结局
- Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL(12 Weeks post-randomization)
- Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL(12 Weeks post-randomization)
- Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL(12 Weeks post-randomization)
- Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL(12 Weeks post-randomization)
- Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL(12 Weeks post-randomization)
- Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL(12 Weeks post-randomization)
研究者
Aristidis Veves
Rongxiang Xu, MD Professor of Surgery in the Field of Regenerative Therapeutics
Beth Israel Deaconess Medical Center