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Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

This study has been withdrawn prior to enrollment.
(investigator took study to university hospital duesseldorf)
Heinrich-Heine University, Duesseldorf
Information provided by:
RWTH Aachen University Identifier:
First received: October 10, 2008
Last updated: September 22, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Peripheral Artery Disease Dietary Supplement: high dose flavanoids Dietary Supplement: low dose flavanoids Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Vascular function [ Time Frame: before treatment and after 30 and 60 days ]

Secondary Outcome Measures:
  • pain free walking distance [ Time Frame: before treatment and 30 and 60 days afterwards ]

Enrollment: 0
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatement with low dose flavanoids over 60 days
Dietary Supplement: low dose flavanoids
treatment with flavanoid-low cocoa two times daily over 60 days
Experimental: 2
Treatment with high dose flavanoids over 60 days
Dietary Supplement: high dose flavanoids
flavanoid rich cocoa 2 times daily over 60 days

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00771797

Heinrich-Heine-University, Düsseldorf
Düsseldorf, Germany, 40225
Sponsors and Collaborators
RWTH Aachen University
Heinrich-Heine University, Duesseldorf
Principal Investigator: Tienush Rassaf, MD Clinic for Cardiology, University Düsseldorf
  More Information

Responsible Party: Heinrich-Heine-University Düsseldorf, Clinic for Cardiology Identifier: NCT00771797     History of Changes
Other Study ID Numbers: PAOD Study
Study First Received: October 10, 2008
Last Updated: September 22, 2015

Keywords provided by RWTH Aachen University:
vascular function
in diabetics with PAOD

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases processed this record on September 21, 2017