CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Tauroursodeoxycholic acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01877551
NCT01877551N/ACompleted

Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

Washington University School of Medicine·interventional·Posted Jun 13, 2013·Updated Jan 27, 2020

In Brief

A clinical study evaluating Tauroursodeoxycholic acid and Placebo tablet for HIV Related Insulin Resistance and 2 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 13, 2013
Enrollment StartSep 1, 2013
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.1 years ago

Interventions

Tauroursodeoxycholic aciddrug

The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.

Placebo tabletother

The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.