Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Heinrich-Heine University, Duesseldorf
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- painfree walking distance
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.
Detailed Description
62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled. Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days. The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion
Investigators
Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Heinrich-Heine University, Duesseldorf
Eligibility Criteria
Inclusion Criteria
- •peripheral artery disease (Fontaine IIb)
- •diabetes mellitus
- •\> 18 years
Exclusion Criteria
- •acute and terminal renal failure
- •acute infection
- •heart failure (NYHA III-IV)
- •arrhythmias
Outcomes
Primary Outcomes
painfree walking distance
Time Frame: 60 days
Secondary Outcomes
- endothelial function(60 days)