N/A
N=27
Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
HIV Related Insulin Resistance · Protease Inhibitor Related Insulin Resistance · Endoplasmic Reticulum Stress
Bottom Line
View on ClinicalTrials.gov: NCT01877551 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Glucose Uptake — 0; 8 change in glucose infusion rate (ml/hr)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tauroursodeoxycholic acid (Drug); Placebo tablet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Uptake |
0; 8 | — |
| SECONDARY Body Composition |
35.7; 32.6; 35.7; 31.7 | — |
| SECONDARY Liver Fat |
-0.3; 1.2 | — |
| SECONDARY Liver Function Tests |
25; 21; 19; 23 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01877551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.