Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
NCT ID: NCT01574820
Last Updated: 2012-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
105 participants
INTERVENTIONAL
2006-11-30
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue
NCT01150981
Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.
NCT00154011
A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients
NCT00349427
Rosiglitazone to Reverse Metabolic Defects in Diabetes
NCT00094796
Rosiglitazone In Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin
NCT00329225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
placebo
placebo tablet
placebo tablet for 6 months
rosiglitazone (4 mg)/day
rosiglitazone (4 mg)/day
rosiglitazone (4 mg)/day for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
placebo tablet
placebo tablet for 6 months
rosiglitazone (4 mg)/day
rosiglitazone (4 mg)/day for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* insulin resistance or glucose intolerance
* 18 to 80 years of age
Exclusion Criteria
* allergy to TZD
* active inflammation
* chronic disease under NSAID treatment
* active heart failure
* unwilling or unable to sign inform consents
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cheng-Kung University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCKUH HR95-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.