Observational Study of Liver Lipid Metabolism in Alcohol Use Disorder

This observational study is looking at how the liver's fat (lipid) metabolism changes in people with Alcohol Use Disorder. Researchers will perform a liver biopsy when you first enter a detoxification program and another one about four weeks later, after your liver fat has resolved. They will then compare the genetic activity (transcriptome changes) in your liver between these two time points to understand how alcohol affects liver fat and how it recovers. This study aims to understand the underlying mechanisms of these changes. You may be eligible if you are 18 to 100 years old, enrolled in study 14-AA-0181, seeking inpatient treatment, and have specific liver elasticity measurements (Vibration Controlled Elastography parameters with initial CAP of >295dB/m). The study is currently unclear on its status and plans to enroll 25 participants.

Study design
This is an observational study, not testing a new treatment. It plans to include 25 participants.
What's involved
You would undergo two liver biopsies: one during the first week of admission to a detoxification program and another in the fourth week.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured between week 1 and week 4 of alcohol cessation, with measurements taken at November 2029.

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NCT07191561

Hepatic Lipid Metabolism-Alcohol Use Disorder

Recruiting
Not specifiedAges 18+Observational
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~25 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Liver biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.
Measured over November 2029
Alcohol Use Disorder
1 sites across 1 states
Maryland1
  • Theo Heller, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Eligibility criteria

Inclusion

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

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.
  • Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.November 2029

    Analysis of liver biopsies