Cocoa Flavanols and Painfree Walking Distance
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Purpose
To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Artery Disease Diabetes Mellitus |
Other: cocoa |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients |
- painfree walking distance [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- endothelial function [ Time Frame: 60 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 62 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: flavanol rich cocoa drink (596mg)
dissolved in water, twice daily intervention
|
Other: cocoa
dissolved in water twice-daily intervention
|
|
Experimental: flavanol poor cocoa drink ( 13mg)
dissolved in water, twice daily intervention
|
Other: cocoa
dissolved in water twice-daily intervention
|
Detailed Description:
62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled.
Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days.
The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- peripheral artery disease (Fontaine IIb)
- diabetes mellitus
- > 18 years
Exclusion Criteria:
- acute and terminal renal failure
- acute infection
- heart failure (NYHA III-IV)
- arrhythmias
Contacts and Locations| Contact: Yvonne Heinen, MD | 0211-8117993 | yvonne.heinen@med.uni-duesseldorf.de |
| Germany | |
| Heinrich Heine University | Recruiting |
| Düsseldorf, NRW, Germany, 40225 | |
| Contact: Yvonne Heinen, MD 0211-8117993 yvonne.heinen@med.uni-duesseldorf.de | |
| Principal Investigator: Christian Heiss, Dr. | |
| Sub-Investigator: Yvonne Heinen, Dr. | |
| Principal Investigator: | Christian Heiss, MD | Heinrich Heine University |
| Study Chair: | Malte Kelm, MD | Heinrich Heine University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Klinik für Kardiologie, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf |
| ClinicalTrials.gov Identifier: | NCT01064583 History of Changes |
| Other Study ID Numbers: | Flavanols-PAD |
| Study First Received: | February 5, 2010 |
| Last Updated: | June 6, 2012 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Diabetes Mellitus Peripheral Arterial Disease Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Atherosclerosis |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013