Eye Blood Flow and the Kidney
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in ophthalmic artery blood flow from baseline
研究概览
简要总结
The purpose of this study is to the determine the effect of salt intake and Captopril on the ophthalmic artery (OA) blood supply of individuals with Type 2 Diabetes Mellitus.
详细描述
The overall objective of this study is to ascertain if salt intake affects ophthalmic artery (OA) blood flow. In addition, we will study both the eye and kidney response to ACE inhibition compared to placebo while controlling salt intake in subjects with Type 2 diabetes mellitus.
We hypothesize that salt intake will affect OA blood flow.
We will initially look at both eye and renal response to subjects on a low salt diet (10mEq Na/day) followed by response to high salt diet (200mEq Na/day). In addition, we may look at eye response while subjects consume their regular diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
排除标准
- •Type 1 Diabetes Mellitus
- •Heart Attack or Stroke within the last 6 months
- •Pregnant or lactating females
研究组 & 干预措施
Arm A
Captopril 25 mg (Admission 1, Day 1, low salt diet) Matched Placebo (Admission 1, Day 2, low salt diet) Captopril 25 mg (Admission 2, Day 1, high salt diet) Matched Placebo (Admission 2, Day 2, high salt diet)
干预措施: Captopril (Drug)
Arm A
Captopril 25 mg (Admission 1, Day 1, low salt diet) Matched Placebo (Admission 1, Day 2, low salt diet) Captopril 25 mg (Admission 2, Day 1, high salt diet) Matched Placebo (Admission 2, Day 2, high salt diet)
干预措施: placebo (Drug)
Captopril
Matched Placebo (Admission 1, Day 1, low salt diet) Captopril 25 mg (Admission 1, Day 2, low salt diet) Matched Placebo (Admission 2, Day 1, high salt diet) Captopril 25 mg (Admission 2, Day 2, high salt diet)
干预措施: Captopril (Drug)
Captopril
Matched Placebo (Admission 1, Day 1, low salt diet) Captopril 25 mg (Admission 1, Day 2, low salt diet) Matched Placebo (Admission 2, Day 1, high salt diet) Captopril 25 mg (Admission 2, Day 2, high salt diet)
干预措施: placebo (Drug)
结局指标
主要结局
Change in ophthalmic artery blood flow from baseline
时间窗: 1 hour post drug, 2 hours post drug, 3 hours post drug
Eye blood flow will be measured at baseline and post drug time points (3 total)
次要结局
- Change in blood pressure from baseline(Every 15 minutes for 3 hours)
- Change in renal plasma flow (RPF) from baseline(1 hour post drug, 2 hours post drug, 3 hours post drug)
研究者
Norman K. Hollenberg, MD, PhD
Director of Physiologic Research Division, Department of Radiology
Brigham and Women's Hospital