Recruiting

Observational StudyHepatic Lipid Metabolism-Alcohol Use Disorder

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Code:

NCT07191561

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Liver biopsy

Study Details

Brief summary:

Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,

Conditions

Alcohol Use Disorder

Study ID

NCT07191561

Start date

Sep 10, 2026

Status verified date

Aug 18, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Liver biopsy

All participants in the study will undergo liver biopsies

Interventions

Liver biopsy

Biopsy of the liver

Primary outcome measure

Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation. [ Time Frame: November 2029 ]

Central Contacts and Locations

Central contacts

Sawsan Fathma, M.D.

(301) 451-1273 sawsan.fathma@nih.gov

Theo Heller, M.D.

(301) 402-7147 theoh@intra.niddk.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222 ccopr@nih.gov

More Information

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Last update posted

Sep 8, 2026

Last verified

Aug 18, 2026

Keywords

Alcohol
Liver
Biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-09-08.