Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: HIV Protease Inhibitors; Insulin; Protease Inhibitors; Taurochenodeoxycholic Acid; Tauroursodeoxycholic acid; Ursodoxicoltaurine

Criteria

Inclusion Criteria:

• HIV+

• receiving protease inhibitor containing antiretroviral therapy for >6 months

• Undetectable viral load

• insulin resistant

1. impaired fasting glucose (fasting blood glucose>100mg/dl)

2. 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