Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Dietary Supplement: high dose flavanoids
* Dietary Supplement: low dose flavanoids


Participation Criteria
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Eligibility Criteria
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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% Malignoms Terminal renal failure with hemodialysis Relevant cardiac arrhythmias Acute inflammation defined as CRP >0,5 mg/dl PAOD (level IV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatement with low dose flavanoids over 60 days | Dietary Supplement: low dose flavanoids<br>* treatment with flavanoid-low cocoa two times daily over 60 days<br>|
| Experimental: 2<br>Treatment with high dose flavanoids over 60 days | Dietary Supplement: high dose flavanoids<br>* flavanoid rich cocoa 2 times daily over 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function |  | before treatment and after 30 and 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain free walking distance |  | before treatment and 30 and 60 days afterwards | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAOD, diabetis, vascular function, in diabetics with PAOD