TART - Troglitazone Atherosclerosis Regression Trial

NCT00116545 | Completed Phase 2

• 2 other identifiers: AG0028991-081-00
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.

Conditions

Atherosclerosis; Diabetes Mellitus

Keywords

IDDM; Insulin; cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months

• flow mediated brachial artery vasoactivity

Secondary Outcomes (1)

• carbohydrate and lipid metabolism

Interventions

troglitazone DRUG

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ages 30-70 years
• Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions
• At least 30 years of age at onset of diabetes
• Metabolic control and management requiring insulin without other anti-diabetic medications
• Willingness to sign informed consent

You may not qualify if:

• Known sensitivity to troglitazone or other thiazolidinediones
• For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial
• Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization
• Medical illness that may require oral or parenteral glucocorticoid therapy
• Physical disability that would interfere with diabetes self-management
• Untreated or unstable diabetic retinopathy
• History of insulin allergy
• Present or recent history of alcohol intake over 5 drinks per day or substance abuse
• Participation in another clinical trial
• Currently taking nicotinic acid

Sponsors & Collaborators

• Parke-Davis: lead

Study Sites (1)

Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Resistance; Cardiovascular Diseases

Interventions

Troglitazone

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Howard N. Hodis, MD

  University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2005
• First Posted: June 30, 2005
• Study Start: January 1, 1997
• Primary Completion: April 1, 2000
• Study Completion: April 1, 2000
• Last Updated: December 11, 2009

Record last verified: 2005-06

Locations

US (1)