Hepatic Lipid Metabolism-Alcohol Use Disorder
Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics
2 other identifiers
observational
25
1 country
1
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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2025
CompletedFirst Posted
Study publicly available on registry
September 25, 2025
CompletedStudy Start
First participant enrolled
April 21, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
Study Completion
Last participant's last visit for all outcomes
November 30, 2029
April 16, 2026
April 6, 2026
1.6 years
September 24, 2025
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.
Analysis of liver biopsies
November 2029
Secondary Outcomes (1)
Other transcriptome changes between week 1 and week 4 of alcohol cessation
November 2029
Study Arms (1)
Liver biopsy
All participants in the study will undergo liver biopsies
Interventions
Eligibility Criteria
Participants diagnosed with alcohol use disorder, currently under inpatient treatment at the NIH.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Theo Heller, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2025
First Posted
September 25, 2025
Study Start (Estimated)
April 21, 2026
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2029
Last Updated
April 16, 2026
Record last verified: 2026-04-06
Data Sharing
- IPD Sharing
- Will not share