Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Vascular function
研究概览
简要总结
To assess the clinical efficacy and to simultaneously explore the underlying molecular mechanisms of the beneficial effects of flavanol-rich cocoa on vascular function diabetic patients with peripheral artery occlusive diseases (PAOD) of the lower extremities will be investigated.
详细描述
50 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 200 m will be enrolled. In a randomized controlled parallel group study the before established novel 5-level approach of vascular diagnostics will be realised. In order to test the hypothesis, whether cocoa rich in flavanols improves vascular function of diabetic PAOD subjects will regularly intake flavanol rich cocoa (group 1: 975 mg/d, n=50 versus group 2: 90 mg/d, n=50) over a period of two months. Clinical endpoints are the Ankle-Brachial-Index, measured by Doppler ultrasound and the pain-free walking distance determined by a treadmill ergometer. All parameters of vascular diagnostic (see 5-level approach above) will be determined before and two month after cocoa ingestion.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 2 defined by the criteria of the American Diabetes Association
- •Fasted plasma glucose greater than 126 mg/dL
- •Plasma glucose levels greater than 200 mg/dL 2 hours after OGT
- •Casual plasma glucose greater than 200 mg/dL combined with diabetic symptoms.
- •Endothelial dysfunction defined by FMD <4%
- •No changes of medication for 2 months
- •Significant PAOD (level IIb, III)
排除标准
- •Ejection fraction <30%
- •Terminal renal failure with hemodialysis
- •Relevant cardiac arrhythmias
- •Acute inflammation defined as CRP >0,5 mg/dl
- •PAOD (level IV)
结局指标
主要结局
Vascular function
时间窗: before treatment and after 30 and 60 days
次要结局
- pain free walking distance(before treatment and 30 and 60 days afterwards)