Peripheral Artery Disease, Diabetes Mellitus
Conditions
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
Interventions
OTHERcocoa
dissolved in water twice-daily intervention
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| painfree walking distance | 60 days |
Secondary
| Measure | Time frame |
|---|---|
| endothelial function | 60 days |
Countries
Germany
Outcome results
None listed