NCT07191561

Hepatic Lipid Metabolism-Alcohol Use Disorder

Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liver biopsy	Biopsy of the liver

Timeline

• Start date: 2026-04-22
• Primary completion: 2027-11-30
• Completion: 2029-11-30
• First posted: 2025-09-25
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States