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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00771797
Other study ID # PAOD Study
Secondary ID
Status Withdrawn
Phase Phase 2
First received October 10, 2008
Last updated September 22, 2015
Start date October 2008
Est. completion date December 2009

Study information

Verified date September 2015
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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

Locations

Country Name City State
Germany Heinrich-Heine-University, Düsseldorf Düsseldorf

Sponsors (2)

Lead Sponsor Collaborator
RWTH Aachen University Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vascular function before treatment and after 30 and 60 days No
Secondary pain free walking distance before treatment and 30 and 60 days afterwards No
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