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NCT01877551 · ClinicalTrials.gov registry record · NA

Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
27
Enrollment target

NCT01877551: Completed NA study, sponsored by Washington University School of Medicine.

NCT01877551 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01877551, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
27 participants
Enrollment target

Study 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.

Primary Outcome

We will examine the ability of insulin to cause muscle to take up insulin. Each subject will receive intravenous insulin for 6 hours to see how much sugar needs to be given intravenously to keep the blood sugar normal, a measure called glucose uptake. We will compare glucose uptake measured as the amount of 20% dextrose that is needed to keep the blood sugar at \~100mg/dl during insulin infusion before and after 30 days of treatment with drug or placebo.

Interventions

  • OTHER Placebo tablet
  • DRUG Tauroursodeoxycholic acid

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2013-09
Est. Completion 2018-05
Phase NA

What the finished NCT01877551 record still lists

NCT01877551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo tablet is the first listed.

NCT01877551 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01877551 about?

NCT01877551 is a clinical study titled "Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance". 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. Tauroursodeoxy...

What is the current status of trial NCT01877551?

This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2013-09. Estimated completion is 2018-05.

What interventions are being tested in trial NCT01877551?

The interventions under investigation include: Placebo tablet (OTHER), Tauroursodeoxycholic acid (DRUG).

Who is sponsoring clinical trial NCT01877551?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01877551's enrollment target sits among peer trials

27 1708th of 2000 higher than 291 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01877551, the US trial registry maintained by the National Library of Medicine. NCT01877551 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.