Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment
NCT ID: NCT00771797
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Treatement with low dose flavanoids over 60 days
low dose flavanoids
treatment with flavanoid-low cocoa two times daily over 60 days
2
Treatment with high dose flavanoids over 60 days
high dose flavanoids
flavanoid rich cocoa 2 times daily over 60 days
Interventions
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high dose flavanoids
flavanoid rich cocoa 2 times daily over 60 days
low dose flavanoids
treatment with flavanoid-low cocoa two times daily over 60 days
Eligibility Criteria
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Inclusion Criteria
* 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
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)
18 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Clinic for Cardiology
Principal Investigators
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Tienush Rassaf, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Cardiology, University Düsseldorf
Locations
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Heinrich-Heine-University, Düsseldorf
Düsseldorf, , Germany
Countries
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Other Identifiers
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PAOD Study
Identifier Type: -
Identifier Source: org_study_id
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