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Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01574820
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Prediabetes Coronary Artery Disease Insulin Resistance Glucose Intolerance Drug: placebo tablet Drug: rosiglitazone (4 mg)/day Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
Study Start Date : November 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo tablet
placebo tablet for 6 months
Experimental: rosiglitazone (4 mg)/day Drug: rosiglitazone (4 mg)/day
rosiglitazone (4 mg)/day for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Biomarkers measurements [ Time Frame: Biomarkers were taken before the trial and 6 months later ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented CAD by angiography
  • insulin resistance or glucose intolerance
  • 18 to 80 years of age

Exclusion Criteria:

  • under DM treatment
  • allergy to TZD
  • active inflammation
  • chronic disease under NSAID treatment
  • active heart failure
  • unwilling or unable to sign inform consents
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01574820    
Other Study ID Numbers: NCKUH HR95-10
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012
Keywords provided by National Cheng-Kung University Hospital:
prediabetes
coronary artery disease
insulin resistance
glucose intolerance
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Insulin Resistance
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperinsulinism
Hyperglycemia
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs