Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
Completed · Not applicable · Has a placebo group
Conditions studied: HIV Related Insulin Resistance, Protease Inhibitor Related Insulin Resistance, Endoplasmic Reticulum Stress
In brief
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 by \~50% of HIV infected people in the USA is an established risk factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt, improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin action in people with HIV who are receiving PI-ART. Further, this project will clarify the molecular mechanisms responsible for these improvements potentially benefiting society, irrespective of HIV status.
Key facts
- Study ID
- NCT01877551
- Run by
- Washington University School of Medicine
- People needed
- 27
- Starts
- 2013-09-01
- Expected to finish
- 2018-05-01
- Last updated by the study team
- 2020-01-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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