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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT00771797
First received: October 10, 2008
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Vascular function [ Time Frame: before treatment and after 30 and 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain free walking distance [ Time Frame: before treatment and 30 and 60 days afterwards ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771797

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

No publications provided

Responsible Party: Heinrich-Heine-University Düsseldorf, Clinic for Cardiology
ClinicalTrials.gov Identifier: NCT00771797     History of Changes
Other Study ID Numbers: PAOD Study
Study First Received: October 10, 2008
Last Updated: July 21, 2010
Health Authority: Germany: Ethics Committee

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013