Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT07191561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Lipid Metabolism-Alcohol Use Disorder
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 001764-DK | None | None | View |