Insulin Resistance and Intramyocellular Lipid Content in Glucose Intolerant Subjects Receiving Rosiglitazone

Completed · Phase 4 · Has a placebo group

Conditions studied: Insulin Sensitivity

In brief

This study will include subjects with an abnormal glucose tolerance test. Using a crossover design, we will evaluate the insulin sensitivity and intracellular lipid content of the heart, liver and skeletal muscle of subjects before and after therapy with Rosiglitazone and placebo. We hypothesize that Rosiglitazone will improve insulin sensitivity in association with reduced muscle lipid content that may arise either from increased lipid oxidation or enhanced storage of fat in adipose tissue.

Key facts

Study ID

NCT00746174

Run by

University of Texas Southwestern Medical Center

People needed

24

Starts

2004-02-01

Expected to finish

2008-02-01

Last updated by the study team

2008-09-03

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 30-65
• Fasting plasma glucose < 126 mg/dL or plasma glucose > 140 mg/dL and <200 mg/dL two hours after a challenge with 75 gm of glucose

You may not qualify if…

• Taking drugs known or suspected to affect intermediary metabolism (e.g. thyroid supplements, oral glucocorticoids, anabolic steroids or androgens, antidepressants, anorexic drugs, xanthine derivatives, sympathomimetics, beta-agonists)
• Taking any other investigational drugs within 30 days of starting the study
• Alcohol consumption more than 7 drinks per week
• Recreational drugs or IV drug abuse
• Acute or chronic liver diseases (SGOT >42 U/L, SGPT >48 U/L, GGT >45 U/L)
• Chronic renal insufficiency (serum creatinine >1.5 mg/dL)
• Uncontrolled hypertension (systolic/diastolic blood pressure >160/95mmHg)
• Anemia (hematocrit <35%)
• Congestive heart failure
• Metallic prostheses precluding the use of magnetic resonance imaging
• Premenopausal women without definitive measures to prevent pregnancy

Where it is running

• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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