Severe Coronary Artery DiseaseKFONCT00510705
Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease
A study testing exercise training, exercise training + metformin and exercise training + glitazone in people with Severe Coronary Artery Disease and Obesity, run by University of Leipzig at 1 site in Germany.
Trial summary
Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or… Read more about this study
- Who is it for?
- Ages 35 to 75 years, men only
- Conditions the study is for
- Severe Coronary Artery Disease, Obesity, Impaired Glucose Tolerance
- What is being tested?
- exercise training, exercise training + metformin and exercise training + glitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Jul 2012
- Phase
- Interventional
- 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 35 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either impaired glucose tolerance (2 hour plasma glucose concentration > 7.8 and < 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( > 6.0 and < 7.0 mmol/L)
- Body mass index (BMI) > 25
- Severe coronary artery disease determined by coronary angiography
- Male patients aged 35-75 years
Who cannot join
- Diabetes mellitus type I
- Diabetes mellitus type II in combination with glycosylates hemoglobin > 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration > 11.0 mmol/L
- Unstable angina pectoris
- Myocardial infarction within the last 4 weeks
- Reduced left-ventricular systolic function < 30%
Trial locations and contacts
1 site in 1 country.
About this study
Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.
- Being tested
- exercise training, exercise training + metformin, exercise training + glitazone
- Keywords
- adiposity
- Medical subject headings
- Coronary Artery Disease, Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
physical exercise training on a bicycle ergometer daily for 4 weeks
exercise training + metforminOther
physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks
exercise training + glitazoneOther
physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Regular physical exercise training alone Receives: Other: exercise training |
| 2 | Other | Regular physical exercise training + metformin Receives: Other: exercise training + metformin |
| 3 | Other | Regular physical exercise training + glitazone Receives: Other: exercise training + glitazone |
| 4 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in endothelial function in severe coronary artery disease
Measured: 4 weeks
Secondary outcomes (1)
change in metabolic parameters
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 posted2 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Responsible party
- Principal investigator, Axel Linke, University of Leipzig
- Investigators
- Gerhard Schuler, Prof. of Medicine, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510705
- Sponsor's protocol ID
- 0816-2007
- Acronym
- KFO
- Status last verified
- Dec 2014
- First submitted
- 1 Aug 2007
- Last updated
- 27 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00510705
- Acronym / sponsor ID
- KFO / 0816-2007
- Keywords
- adiposity
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Study start
- Jul 2007
- Primary completion
- Jul 2012 (actual)
- First posted
- 2 Aug 2007 (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.
Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: exercise trainingRegular physical exercise training alone |
| 2 | Other | Other: exercise training + metforminRegular physical exercise training + metformin |
| 3 | Other | Other: exercise training + glitazoneRegular physical exercise training + glitazone |
| 4 | No intervention | –Control |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Either impaired glucose tolerance (2 hour plasma glucose concentration > 7.8 and < 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( > 6.0 and < 7.0 mmol/L)
- Body mass index (BMI) > 25
- Severe coronary artery disease determined by coronary angiography
- Male patients aged 35-75 years
Key exclusion criteria (5 listed)
- Diabetes mellitus type I
- Diabetes mellitus type II in combination with glycosylates hemoglobin > 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration > 11.0 mmol/L
- Unstable angina pectoris
- Myocardial infarction within the last 4 weeks
- Reduced left-ventricular systolic function < 30%
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 trainingphysical exercise training on a bicycle ergometer daily for 4 weeks | Other | 1 |
| exercise training + metforminphysical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks | Other | 2 |
| exercise training + glitazonephysical exercise training on a bicycle ergometer + glitazone daily for 4 weeks | Other | 3 |
Primary outcome
change in endothelial function in severe coronary artery disease
Time frame: 4 weeks
1 secondary outcome
change in metabolic parameters
Time frame: 4 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
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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.
Gerhard Schuler, Prof. of Medicine 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 study testing exercise training, exercise training + metformin and exercise training + glitazone in people with Severe Coronary Artery Disease and Obesity, 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Nov 2020. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
change in endothelial function in severe coronary artery disease (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 27 Nov 2020.