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

NCT01574820 | Completed Phase 3

• 1 other identifier: NCKUH HR95-10
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prediabetes; Coronary Artery Disease; Insulin Resistance; Glucose Intolerance

Keywords

prediabetes; coronary artery disease; insulin resistance; glucose intolerance

Outcome Measures

Primary Outcomes (1)

• 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.

  at least 6 months follow-up of MACEs

Secondary Outcomes (1)

• Biomarkers measurements

  Biomarkers were taken before the trial and 6 months later

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo tablet

rosiglitazone (4 mg)/day

EXPERIMENTAL

Drug: rosiglitazone (4 mg)/day

Interventions

placebo tablet DRUG

placebo tablet for 6 months

placebo

rosiglitazone (4 mg)/day DRUG

rosiglitazone (4 mg)/day for 6 months

rosiglitazone (4 mg)/day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• under DM treatment
• allergy to TZD
• active inflammation
• chronic disease under NSAID treatment
• active heart failure
• unwilling or unable to sign inform consents

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

MeSH Terms

Conditions

Prediabetic State; Coronary Artery Disease; Insulin Resistance; Glucose Intolerance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperinsulinism; Hyperglycemia

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 10, 2012
• Study Start: November 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 11, 2012

Record last verified: 2012-04