Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

RWTH Aachen University

Status and phase: Withdrawn; Phase 2

Conditions: Peripheral Artery Disease

Treatments: Dietary Supplement: high dose flavanoids; Dietary Supplement: low dose flavanoids

Study type: Interventional

Funder types: Other

Identifiers

NCT00771797

PAOD Study

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

1

Experimental group

Description:

Treatement with low dose flavanoids over 60 days

Treatment:

Dietary Supplement: low dose flavanoids

2

Experimental group

Description:

Treatment with high dose flavanoids over 60 days

Treatment:

Dietary Supplement: high dose flavanoids