NCT00771797

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

October 10, 2008

Last Update Submit

September 22, 2015

Conditions

Peripheral Artery Disease

Keywords

PAODdiabetisvascular functionin diabetics with PAOD

Outcome Measures

Primary Outcomes (1)

  • Vascular function

    before treatment and after 30 and 60 days

Secondary Outcomes (1)

  • pain free walking distance

    before treatment and 30 and 60 days afterwards

Study Arms (2)

1

EXPERIMENTAL

Treatement with low dose flavanoids over 60 days

Dietary Supplement: low dose flavanoids

2

EXPERIMENTAL

Treatment with high dose flavanoids over 60 days

Dietary Supplement: high dose flavanoids

Interventions

high dose flavanoidsDIETARY_SUPPLEMENT

flavanoid rich cocoa 2 times daily over 60 days

2
low dose flavanoidsDIETARY_SUPPLEMENT

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Endothelial dysfunction defined by FMD \<4%
  • No changes of medication for 2 months
  • Significant PAOD (level IIb, III)

You may not qualify if:

  • Ejection fraction \<30%
  • Malignoms
  • Terminal renal failure with hemodialysis
  • Relevant cardiac arrhythmias
  • Acute inflammation defined as CRP \>0,5 mg/dl
  • PAOD (level IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heinrich-Heine-University, Düsseldorf

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Tienush Rassaf, MD

    Clinic for Cardiology, University Düsseldorf

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DE(1)