Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

NCT ID: NCT00771797

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Treatement with low dose flavanoids over 60 days

Group Type EXPERIMENTAL

low dose flavanoids

Intervention Type DIETARY_SUPPLEMENT

treatment with flavanoid-low cocoa two times daily over 60 days

2

Treatment with high dose flavanoids over 60 days

Group Type EXPERIMENTAL

high dose flavanoids

Intervention Type DIETARY_SUPPLEMENT

flavanoid rich cocoa 2 times daily over 60 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high dose flavanoids

flavanoid rich cocoa 2 times daily over 60 days

Intervention Type DIETARY_SUPPLEMENT

low dose flavanoids

treatment with flavanoid-low cocoa two times daily over 60 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clinic for Cardiology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tienush Rassaf, MD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Cardiology, University Düsseldorf

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Heinrich-Heine-University, Düsseldorf

Düsseldorf, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PAOD Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NK-1 Antagonism of SLV317 in Humans
NCT00160862 COMPLETED PHASE1
Carnosine for Peripheral Arterial Disease
NCT04870229 COMPLETED PHASE2
Carnosine for Peripheral Arterial Disease Patients
NCT05371145 RECRUITING PHASE1/PHASE2