Peripheral Artery Disease Clinical Trial
Official title:
Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD
Verified date | September 2015 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Committee |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. Endothelial dysfunction defined by FMD <4% 3. No changes of medication for 2 months 4. Significant PAOD (level IIb, III) Exclusion Criteria: 1. Ejection fraction <30% 2. Malignoms 3. Terminal renal failure with hemodialysis 4. Relevant cardiac arrhythmias 5. Acute inflammation defined as CRP >0,5 mg/dl 6. PAOD (level IV) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Heinrich-Heine-University, Düsseldorf | Düsseldorf |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University | Heinrich-Heine University, Duesseldorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vascular function | before treatment and after 30 and 60 days | No | |
Secondary | pain free walking distance | before treatment and 30 and 60 days afterwards | No |
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