Impaired Glucose TolerancePhase 4NCT00675740
Physical Exercise Versus Rosiglitazone in CAD and Prediabetes
A Phase 4 study testing rosiglitazone and physical exercise in people with Impaired Glucose Tolerance, run by University of Leipzig.
Trial summary
The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- rosiglitazone and physical exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Feb 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- impaired fasting glucose or impaired glucose tolerance
- angiographic evidence of coronary artery disease
Who cannot join
- diabetes mellitus type I or II
- preexisting antidiabetic medication
- unstable angina
- indication for coronary bypass surgery
- significant left main disease
- myocardial infarction within preceding 3 months
Show all 14Show fewer
- ejection fraction < 40%
- significant heart valve disease
- severe metabolic disorders
- severe disorders in lipoprotein metabolism
- thyroid disorders
- alcohol or drug abuse
- pregnancy
- participation in another trial
About this study
Official title: Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).
- Conditions
- Impaired Glucose Tolerance
- Being tested
- rosiglitazone, physical exercise, control
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosiglitazoneDrug
Also called Avandia (GlaxoSmithKline)
tablets 4 mg daily
physical exerciseBehavioural
stationary bike 5-6 times a week
controlOther
control without intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: rosiglitazone |
| 2 | Active comparator | physical exercise Receives: Behavioral: physical exercise |
| 3 | No intervention | control Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
between-group difference in flow-mediated dilation of the brachial artery
Measured: 6 months
Secondary outcomes (1)
relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startJan 2004
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675740
- Sponsor's protocol ID
- Leipzig 03
- Status last verified
- Jan 2010
- First submitted
- 7 May 2008
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT00675740
- Acronym / sponsor ID
- Leipzig 03
- Conditions
- Impaired Glucose Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 May 2008 (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.
The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rosiglitazone |
| 2 | Active comparator | Behavioral: physical exercisephysical exercise |
| 3 | No intervention | Other: controlcontrol |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- impaired fasting glucose or impaired glucose tolerance
- angiographic evidence of coronary artery disease
Key exclusion criteria (14 listed)
- diabetes mellitus type I or II
- preexisting antidiabetic medication
- unstable angina
- indication for coronary bypass surgery
- significant left main disease
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 |
|---|---|---|
| rosiglitazoneAlso: Avandia (GlaxoSmithKline)tablets 4 mg daily | Drug | 1 |
| physical exercisestationary bike 5-6 times a week | Behavioural | 2 |
| controlcontrol without intervention | Other | 3 |
Primary outcome
between-group difference in flow-mediated dilation of the brachial artery
Time frame: 6 months
1 secondary outcome
relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies
Time frame: 6 months
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 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rosiglitazone and physical exercise in people with Impaired Glucose Tolerance, run by University of Leipzig.
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 2 inclusion and 14 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 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
between-group difference in flow-mediated dilation of the brachial artery (time frame: 6 months). 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 Feb 2010.