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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00771797
First Posted: October 13, 2008
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by:
RWTH Aachen University
  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
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Heinrich-Heine-University Düsseldorf, Clinic for Cardiology
ClinicalTrials.gov Identifier: NCT00771797     History of Changes
Other Study ID Numbers: PAOD Study
First Submitted: October 10, 2008
First Posted: October 13, 2008
Last Update Posted: September 23, 2015
Last Verified: September 2015

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