Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- RWTH Aachen University
- Locations
- 1
- Primary Endpoint
- Vascular function
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •Ejection fraction \<30%
- •Terminal renal failure with hemodialysis
- •Relevant cardiac arrhythmias
- •Acute inflammation defined as CRP \>0,5 mg/dl
- •PAOD (level IV)
Outcomes
Primary Outcomes
Vascular function
Time Frame: before treatment and after 30 and 60 days
Secondary Outcomes
- pain free walking distance(before treatment and 30 and 60 days afterwards)