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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01574820
First received: April 4, 2012
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Biomarkers were taken before the trial and 6 months later ] [ Designated as safety issue: No ]

    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.



Enrollment: 105
Study Start Date: November 2006
Study Completion Date: July 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01574820     History of Changes
Other Study ID Numbers: NCKUH HR95-10
Study First Received: April 4, 2012
Last Updated: April 10, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Cheng-Kung University Hospital:
prediabetes
coronary artery disease
insulin resistance
glucose intolerance

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Insulin Resistance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Hyperglycemia
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014