TART - Troglitazone Atherosclerosis Regression Trial

Diabetes Mellitus Clinical Trial

Official title:

TART - Troglitazone Atherosclerosis Regression Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116545
• Other study ID #: AG0028
• Secondary ID: 991-081-00
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 29, 2005
• Last updated: December 9, 2009
• Start date: January 1997
• Est. completion date: April 2000

Study information

• Verified date: June 2005
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance. Based on the initial data available, it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients. This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis.

A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and glucose levels. Upon successful completion of the run-in phase, all patients were randomized into one of two groups to receive either troglitazone 400mg/day or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mg/dL.

Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every 8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: April 2000
• Est. primary completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus

Intervention

Drug:
• troglitazone

Locations

Country	Name	City	State
United States	Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Parke-Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months
Primary	flow mediated brachial artery vasoactivity
Secondary	carbohydrate and lipid metabolism