Status:
COMPLETED
Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Related Insulin Resistance
Protease Inhibitor Related Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected people than the general population. Protease inhibitor booster antiretroviral therapy (PI-ART) which is used b...
Detailed Description
The purpose of this study is to determine if, and through which mechanisms, tauroursodeoxycholic acid improves insulin sensitivity in subjects with protease-inhibitor associated insulin resistance. T...
Eligibility Criteria
Inclusion
- HIV+
- receiving protease inhibitor containing antiretroviral therapy for \>6 months
- Undetectable viral load
- insulin resistant
- impaired fasting glucose (fasting blood glucose\>100mg/dl)
- impaired glucose tolerance (blood glucose \>140mg/dl at 2 hours during oral glucose tolerance testing).
- abstained from medications that affect glucose (e.g. prednisone, growth hormone)
- stable medications for \>3 months
Exclusion
- weight loss of \>5% of body weight in prior 6 months
- active gastrointestinal disease (gallstones, pancreatitis, hepatitis, diarrhea)
- use of anti-diabetic medications
- cardiovascular disease (uncontrolled hypertension, heart attack, heart failure, prior endocarditis)
- history of or active substance abuse
- blood clotting disorder or taking medications that affect blood clotting (e.g. coumadin, warfarin)
- pregnant, planning to become pregnant or lactating
- unable to give informed consent
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01877551
Start Date
September 1 2013
End Date
May 1 2018
Last Update
January 27 2020
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110