Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 7:39 PM
Study NCT ID:
NCT06764056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Sponsor:
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Organization:
Study Overview
Official Title:
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-12
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:
METAfoie
Brief Summary:
The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:
Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?
Participants will either participate in one of three groups:
* Nutrition: Participant will only have a regular follow-up with a registered dietician;
* Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;
* Semaglutide: Participants will start a new medication targeting obesity.
Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?
Participants will either participate in one of three groups:
* Nutrition: Participant will only have a regular follow-up with a registered dietician;
* Nutrition + Semaglutide: Participants will start a new medication targeting obesity and will have a regular follow-up with a registered dietician;
* Semaglutide: Participants will start a new medication targeting obesity.
Detailed Description:
Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.
The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.
The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: