Hepatic Lipid Metabolism-Alcohol Use Disorder

Not yet recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT07191561
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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,

Detailed Description

Study Description:

The liver is central to lipid metabolism, intimately involved with lipid uptake, lipoprotein synthesis and lipid synthesis. Alcohol has known effects on changing lipid composition including increases in HDL and decreases in LDL; nevertheless, the underlying mechanisms of this altered lipoprotein metabolism is not understood. Current spectroscopy data characterize the changes in lipoprotein profiles with alcohol cessation. We aim to study liver lipid metabolism by performing liver biopsies and transcriptome analysis in participants with alcohol use disorder.

Objectives:

Primary Objective:

To understand the transcriptomics of hepatic lipid metabolism in alcohol use disorder

Secondary Objective:

To understand other transcriptome changes in alcohol use cessation.

Tertiary Objective:

To elucidate the genomics-transcriptomics-metabolomics pathway of hepatic lipid metabolism in alcohol use disorder.

Endpoints:

Primary Endpoints:

-Transcriptome changes in lipid metabolism between week 1 and week 4.

Secondary Endpoints:

-Other transcriptome changes between week 1 and week 4.

Tertiary Endpoints:

* To make connections with existing genetics and metabolomics data with transcriptomics.

* Stool microbiome studies

Study Timeline

• Status Verified: 2025-09-22
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Study First Posted: 2025-09-25
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-09-29
• Study Start: 2025-11-28
• Primary Completion: 2027-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.	November 2029	Analysis of liver biopsies

Secondary Outcome Measures

Name	Time	Method
Other transcriptome changes between week 1 and week 4 of alcohol cessation	November 2029

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States