NCT01272674

Brief Summary

Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by influencing vascular NO bioavailability and concentration and function of endothelial progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell migration and the underlying signaling pathways. Furthermore, the impact of exercise training on adiponectin-mediated endothelial progenitor cell migration will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 coronary-artery-disease

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 2, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

January 7, 2011

Last Update Submit

June 1, 2015

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • migratory capacity of endothelial progenitor cells towards an SDF-1 gradient

    4 weeks

Study Arms (3)

exercise training

ACTIVE COMPARATOR

4 weeks of supervised physical exercise training

Other: exercise training

control

NO INTERVENTION

sedentary lifestyle

healthy control

NO INTERVENTION

Interventions

exercise trainingOTHER

4 weeks supervised physical exercise training

exercise training

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 75 years of age
  • stable coronary artery disease
  • preserved left ventricular function
  • physical work capacity of ≥ 50
  • successful elective percutaneous coronary intervention at study begin

You may not qualify if:

  • diabetes mellitus
  • hypercholesterolemia
  • untreated hypertension
  • smoking
  • myocardial infarction within the last 4 weeks
  • significant stenosis of the left main coronary artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig, Heart Center

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Axel Linke, MD

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 10, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 2, 2015

Record last verified: 2015-06

Locations

DE(1)