Adiponectin and Circulating Progenitor Cells (CPC) Function
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- ≤ 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
Exclusion Criteria:
- diabetes mellitus
- hypercholesterolemia
- untreated hypertension
- smoking
- myocardial infarction within the last 4 weeks
- significant stenosis of the left main coronary artery
Sites / Locations
- University of Leipzig, Heart Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
exercise training
control
healthy control
Arm Description
4 weeks of supervised physical exercise training
sedentary lifestyle
Outcomes
Primary Outcome Measures
migratory capacity of endothelial progenitor cells towards an SDF-1 gradient
Secondary Outcome Measures
Full Information
NCT ID
NCT01272674
First Posted
January 7, 2011
Last Updated
June 1, 2015
Sponsor
University of Leipzig
Collaborators
German Research Foundation, Heart Center Leipzig - University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01272674
Brief Title
Adiponectin and Circulating Progenitor Cells (CPC) Function
Official Title
Adiponectin Promotes the Migration of Circulating Progenitor Cells Through p38-mediated Induction of the CXCR4 Receptor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
German Research Foundation, Heart Center Leipzig - University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise training
Arm Type
Active Comparator
Arm Description
4 weeks of supervised physical exercise training
Arm Title
control
Arm Type
No Intervention
Arm Description
sedentary lifestyle
Arm Title
healthy control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
4 weeks supervised physical exercise training
Primary Outcome Measure Information:
Title
migratory capacity of endothelial progenitor cells towards an SDF-1 gradient
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≤ 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
Exclusion Criteria:
diabetes mellitus
hypercholesterolemia
untreated hypertension
smoking
myocardial infarction within the last 4 weeks
significant stenosis of the left main coronary artery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Linke, MD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig, Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Adiponectin and Circulating Progenitor Cells (CPC) Function
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