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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: GlaxoSmithKline
• Treatments: Insulin; Insulin, Globin Zinc; Rosiglitazone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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