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Liver biopsies reveal Fat-Busting secrets in alcohol detox

NCT ID NCT07191561

Knowledge-focused Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 21, 2026 · Updated 60 times

Summary

This study looks at how the liver processes fat in people with alcohol use disorder who are quitting drinking. Researchers will take two small liver samples—one early in detox and one after four weeks—to compare gene activity. The goal is to understand how the liver clears fat when alcohol is removed, which could help develop future treatments for alcohol-related liver disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal how the liver recovers from alcohol-related fat buildup, pointing toward new ways to treat or prevent liver damage.
What could go wrong
This is a very small, early-stage observational study with only 25 participants. It does not test a treatment, so results may not lead to direct medical advances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants diagnosed with alcohol use disorder, currently under inpatient treatment at the NIH.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Any individual \>=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment. * Vibration Controlled Elastography parameters with initial CAP of \>295dB/m. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Pregnancy * Existing diagnosis of hyperlipidemia or essential hypertension * Hemoglobin A1c \>= 6.5% * Waist to hip ratio: \>=0.90 in males, \>=0.85 in females * Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia. * Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function \> 32 * Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease) * HIV infection * Contraindication or inability to perform a liver biopsy. * Participants with coagulopathy (PT/PTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\< 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy. * Hemoglobin level \< 11 g/dL * Inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcoholic fatty liver disease fatty liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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