Status:
COMPLETED
Insulin Resistance and Intramyocellular Lipid Content in Glucose Intolerant Subjects Receiving Rosiglitazone
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Insulin Sensitivity
Eligibility:
All Genders
30-65 years
Phase:
PHASE4
Brief 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 ske...
Detailed Description
This protocol is a crossover study that will include subjects with an abnormal glucose tolerance test. Participants will be treated in a community-based practice setting and will receive detailed inst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00746174
Start Date
February 1 2004
End Date
February 1 2008
Last Update
September 3 2008
Active Locations (1)
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1
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390