Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

Phase 2

Withdrawn

• Conditions: Peripheral Artery Disease
• Interventions: Dietary Supplement: low dose flavanoids; Dietary Supplement: high dose flavanoids

• Registration Number: NCT00771797
• Lead Sponsor: RWTH Aachen University

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	low dose flavanoids	Treatement with low dose flavanoids over 60 days
2	high dose flavanoids	Treatment with high dose flavanoids over 60 days

Primary Outcome Measures

Name	Time	Method
Vascular function	before treatment and after 30 and 60 days

Secondary Outcome Measures

Name	Time	Method
pain free walking distance	before treatment and 30 and 60 days afterwards

Trial Locations

Locations (1)

Heinrich-Heine-University, Düsseldorf; 🇩🇪 Düsseldorf, Germany