Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease
NCT ID: NCT00835887
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WITHDRAWN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
Brief Summary
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Detailed Description
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It is expected that flavanols dose-dependently improve vascular function and that this is associated with an increase in the circulating NO pool.
In order to assess long-term effects of flavanols on vascular function in patients with ESRD.
To characterize potential vascular long-term effects of flavanols in patients with ESRD, a placebo-controlled double-blinded randomized control study will be performed in 40 patients randomized in two groups. Patients will daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of three months.
The flavanol-dosis that is necessary to affect vascular function will be assessed as described above. At the beginning of the study, after the first intake of the cocoa (in order to identify nonresponders) and monthly for a period of three months the vascular function will be assessed applying innovative imaging techniques to the brachial artery to assess endothelium-dependent regulation of physicomechanical properties and vascular tone and thus blood flow at the level of the macrocirculation. In parallel new techniques will be applied to assess perfusion at the level of the microcirculation. In particular, measurement of flow-mediated dilation, intima-media-thickness,compliance and stiffness indices will be performed in the macrocirculation of the brachial artery.
Considering the microcirculation, new diagnostic approaches such as Laser-Doppler Flow and peripheral arterial tonometry next to diagnostic approaches such as the venous occlusive plethysmography will be performed. Moreover, the circulating NO pool, markers of inflammation and of oxidative stress, the uremic toxin pcresol and the plasma levels of flavanols will be determined. The exams after month 1, 2, and 3 will be performed in the morning before intake of the cocoa drink. In order to examine potential sustained effects, an additional examination day will take place after 4 month (one month after stopping the flavanol-intake). It is expected that the flavanol-rich cocoa will improve vascular function, which is associated with an increase in the circulating NO-pool and a decrease in inflammatory markers and the marker for oxidative stress.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Treatment with low dose flavanoids
low and high dose flavanoids
treatment with flavanoid-rich or flavanoid-low cacao twice daily
2
Treatment with high dose flavanoids
low and high dose flavanoids
treatment with flavanoid-rich or flavanoid-low cacao twice daily
Interventions
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low and high dose flavanoids
treatment with flavanoid-rich or flavanoid-low cacao twice daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* participation in another study
18 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Department of Medicine, Divison of Cardiology, Pulmonology and Vascular Medicine
Locations
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Düsseldorf University Hospital
Düsseldorf, , Germany
Countries
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Other Identifiers
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ESRD-Study
Identifier Type: -
Identifier Source: org_study_id
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