Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Global [11C]HED Retention Index (RI)
研究概览
简要总结
The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Mild neuropathy
- •Mild retinopathy
- •Mild nephropathy
排除标准
- •History of drug or alcohol dependence, heart disease, viral illness, liver disease, advanced kidney disease
- •Pregnant or nursing
- •Severely overweight
研究组 & 干预措施
ORAL ANTIOXIDANT
Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally These drugs were given together as a combination and not as individual treatment.
干预措施: ORAL ANTIOXIDANT (Drug)
Placebo
Placebo administered twice daily.
干预措施: ORAL ANTIOXIDANT (Drug)
结局指标
主要结局
Global [11C]HED Retention Index (RI)
时间窗: Baseline, 24 months
Distal defects in \[11C\]meta-hydroxyephedrine (\[11C\]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as \[11C\]HEDblood min -1\[ml tissue\]-1 PET Data of Randomized Subjects at Baseline and 24-Months The primary outcome was the change in the global \[11C\]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo.
次要结局
- Global Coronary Flow Reserve as a Measure of Endothelial Function(Baseline, 24 months)
- Systemic Oxidative Stress(24 months)
- Inflammation(24 months)
研究者
Rodica Pop-Busui
Associate Professor
University of Michigan