Adiponectin and Circulating Progenitor Cells (CPC) Function | NCT01272674

Studies
Adiponectin and Circulating Progenitor Cells (CPC) Function

NCT01272674

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Jun 2, 2015Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Coronary Artery Disease

Interventions

exercise training

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jan 7, 2011

First Submission Date that Met QC Criteria

Jan 7, 2011

First Posted Date

Jan 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2015

Last Update Posted Date

Jun 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. med. A. Linke, Co-investigator, University of LeipzigPrincipal Investigator

Lead Sponsor

University of LeipzigOTHER

Collaborators

Name	Class
German Research Foundation	OTHER
Heart Center Leipzig - University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise training	Active Comparator	4 weeks of supervised physical exercise training	Other: exercise training
control	No Intervention	sedentary lifestyle
healthy control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise training	Other	4 weeks supervised physical exercise training	exercise training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
migratory capacity of endothelial progenitor cells towards an SDF-1 gradient		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Axel Linke, MD	Heart Center Leipzig - University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig, Heart Center		Leipzig		04289	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided