Coronary Artery DiseasePhase 1NCT01272674
Adiponectin and Circulating Progenitor Cells (CPC) Function
A Phase 1 study testing exercise training in people with Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≤ 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
Who cannot join
- diabetes mellitus
- hypercholesterolemia
- untreated hypertension
- smoking
- myocardial infarction within the last 4 weeks
- significant stenosis of the left main coronary artery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adiponectin Promotes the Migration of Circulating Progenitor Cells Through p38-mediated Induction of the CXCR4 Receptor
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.
- Conditions
- Coronary Artery Disease
- Being tested
- exercise training
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
4 weeks supervised physical exercise training
| Study group | Role | What they receive |
|---|---|---|
| exercise training | Active comparator | 4 weeks of supervised physical exercise training Receives: Other: exercise training |
| control | No intervention | sedentary lifestyle |
| healthy control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
migratory capacity of endothelial progenitor cells towards an SDF-1 gradient
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Heart Center Leipzig - University Hospital
- Responsible party
- Principal investigator, Prof. Dr. med. A. Linke, University of Leipzig
- Investigators
- Axel Linke, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272674
- Sponsor's protocol ID
- adipo2008
- Status last verified
- Jun 2015
- First submitted
- 7 Jan 2011
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiponectin Promotes the Migration of Circulating Progenitor Cells Through p38-mediated Induction of the CXCR4 Receptor
- ClinicalTrials.gov ID
- NCT01272674
- Acronym / sponsor ID
- adipo2008
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- German Research Foundation, Heart Center Leipzig - University Hospital
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise training | Active comparator | Other: exercise training4 weeks of supervised physical exercise training |
| control | No intervention | –sedentary lifestyle |
| healthy control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≤ 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
Key exclusion criteria (6 listed)
- diabetes mellitus
- hypercholesterolemia
- untreated hypertension
- smoking
- myocardial infarction within the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training4 weeks supervised physical exercise training | Other | exercise training |
Primary outcome
migratory capacity of endothelial progenitor cells towards an SDF-1 gradient
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Linke, MD principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing exercise training in people with Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
migratory capacity of endothelial progenitor cells towards an SDF-1 gradient (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.