Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT07191561
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:
NCT07191561
Study Brief:
Protocol Section:
NCT07191561