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

Primary Purpose

Prediabetes, Coronary Artery Disease, Insulin Resistance

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
placebo tablet
rosiglitazone (4 mg)/day
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetes focused on measuring prediabetes, coronary artery disease, insulin resistance, glucose intolerance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    placebo

    rosiglitazone (4 mg)/day

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    April 4, 2012
    Last Updated
    April 10, 2012
    Sponsor
    National Cheng-Kung University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01574820
    Brief Title
    Role of Rosiglitazone on Pre-Diabetes Mellitus and Coronary Artery Disease
    Official Title
    Role of Rosiglitazone Treatment and Secondary Prevention of Cardiovascular Events in Patients With Pre-Diabetes Mellitus and Coronary Artery Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    August 2010 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cheng-Kung University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prediabetes, Coronary Artery Disease, Insulin Resistance, Glucose Intolerance
    Keywords
    prediabetes, coronary artery disease, insulin resistance, glucose intolerance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Title
    rosiglitazone (4 mg)/day
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    placebo tablet
    Intervention Description
    placebo tablet for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    rosiglitazone (4 mg)/day
    Intervention Description
    rosiglitazone (4 mg)/day for 6 months
    Primary Outcome Measure Information:
    Title
    major cardiovascular events, including myocardial infarction, overt heart failure, and surgery or coronary intervention for CAD
    Description
    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.
    Time Frame
    at least 6 months follow-up of MACEs
    Secondary Outcome Measure Information:
    Title
    Biomarkers measurements
    Description
    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.
    Time Frame
    Biomarkers were taken before the trial and 6 months later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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