Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

September 22, 2015 updated by: RWTH Aachen University

Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Heinrich-Heine-University, Düsseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular function
Time Frame: before treatment and after 30 and 60 days
before treatment and after 30 and 60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
pain free walking distance
Time Frame: before treatment and 30 and 60 days afterwards
before treatment and 30 and 60 days afterwards

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Tienush Rassaf, MD, Clinic for Cardiology, University Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAOD Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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