PrediabetesPhase 3NCT01574820
Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
A Phase 3 study testing rosiglitazone (4 mg)/day in people with Prediabetes and Coronary Artery Disease, run by National Cheng-Kung University Hospital.
Trial summary
Objectives: The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD). Background: Microvascular and macrovascular complications are common in type 2 DM. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prediabetes, Coronary Artery Disease, Insulin Resistance
- What is being tested?
- rosiglitazone (4 mg)/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jul 2011
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented CAD by angiography
- insulin resistance or glucose intolerance
- 18 to 80 years of age
Who cannot join
- under DM treatment
- allergy to TZD
- active inflammation
- chronic disease under NSAID treatment
- active heart failure
- unwilling or unable to sign inform consents
About this study
Official title: Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
Objectives:
The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).
Background:
Microvascular and macrovascular complications are common in type 2 DM. There is no evidence about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory process activators) on pre-DM patients with documented CAD.
Read the detailed description
Materials and Methods:
This is a randomized, double-blind, placebo-controlled study, patients will be randomly assigned to the TZD group and to the placebo group with a 6-month treatment period.
Biomarkers will also examined before and 6 months post-treatment during the trial.
The primary end-points will be the diagnosis of major cardiovascular events: myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.
- Being tested
- placebo tablet, rosiglitazone (4 mg)/day
- Keywords
- prediabetes, coronary artery disease, insulin resistance, glucose intolerance
- Medical subject headings
- Prediabetic State, Coronary Artery Disease, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo tabletDrug
placebo tablet for 6 months
rosiglitazone (4 mg)/dayDrug
rosiglitazone (4 mg)/day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo tablet |
| rosiglitazone (4 mg)/day | Experimental | Not described Receives: Drug: rosiglitazone (4 mg)/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
Primary end points: The primary end-point was defined as major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.
Measured: at least 6 months follow-up of MACEs
Secondary outcomes (1)
Biomarkers measurements
Resistin and adiponectin will be measured to evaluate insulin resistance; CCL/MCP-1 and hsCRP were also analyzed to evaluate inflammation status changes.
Several vascular associated remodeling markers and proteins will also be measured.
Measured: Biomarkers were taken before the trial and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startNov 2006
- Primary completionAug 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574820
- Sponsor's protocol ID
- NCKUH HR95-10
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01574820
- Acronym / sponsor ID
- NCKUH HR95-10
- Keywords
- prediabetes, coronary artery disease, insulin resistance, glucose intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Apr 2012 (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.
Objectives:
The investigators examined whether rosiglitazone, a thiazolidinedione (TZD), is beneficial for pre-diabetes mellitus (DM) adults with documented coronary artery disease (CAD).
Background:
Microvascular and macrovascular complications are common in type 2 DM. There is no evidence about the effects of TZDs, synthetic peroxisome proliferator-activated receptor (PPAR)-γ activators (insulin sensitizers and adipose transcriptional regulation and anti-inflammatory process activators) on pre-DM patients with documented CAD.
Detailed description
Materials and Methods:
This is a randomized, double-blind, placebo-controlled study, patients will be randomly assigned to the TZD group and to the placebo group with a 6-month treatment period.
Biomarkers will also examined before and 6 months post-treatment during the trial.
The primary end-points will be the diagnosis of major cardiovascular events: myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo tablet |
| rosiglitazone (4 mg)/day | Experimental | Drug: rosiglitazone (4 mg)/day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- documented CAD by angiography
- insulin resistance or glucose intolerance
- 18 to 80 years of age
Key exclusion criteria (6 listed)
- under DM treatment
- allergy to TZD
- active inflammation
- chronic disease under NSAID treatment
- active heart failure
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 |
|---|---|---|
| placebo tabletplacebo tablet for 6 months | Drug | placebo |
| rosiglitazone (4 mg)/dayrosiglitazone (4 mg)/day for 6 months | Drug | rosiglitazone (4 mg)/day |
Primary outcome
major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
Time frame: at least 6 months follow-up of MACEs
Primary end points: The primary end-point was defined as major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD.
1 secondary outcome
Biomarkers measurements
Time frame: Biomarkers were taken before the trial and 6 months later
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 11 Apr 2012.
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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 3 study testing rosiglitazone (4 mg)/day in people with Prediabetes and Coronary Artery Disease, run by National Cheng-Kung University Hospital.
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 3 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 11 Apr 2012. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD (time frame: at least 6 months follow-up of MACEs). 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 11 Apr 2012.