Peripheral Artery Occlusive Diseases (PAOD) Study - Clinical Assessment

Clinical Study to Assess the Clinical Efficacy of Flavanol-rich Cocoa on Vascular Function in Diabetic Patients With PAOD

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771797

Enrollment

Registered

2008-10-13

Start date

2008-10-31

Completion date

2009-12-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

PAOD, diabetis, vascular function, in diabetics with PAOD

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENThigh dose flavanoids

flavanoid rich cocoa 2 times daily over 60 days

DIETARY_SUPPLEMENTlow dose flavanoids

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Vascular function	before treatment and after 30 and 60 days

Secondary

Measure	Time frame
pain free walking distance	before treatment and 30 and 60 days afterwards

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026