NCT06764056

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metabolic Associated Fatty Liver Disease
• Metabolic Associated-dysfunction Steatohepatitis (MASH)
• Obesity

Interventions

Type	Name	Description
DRUG	semaglutide	Participants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed.
OTHER	Diet	Participants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-01-08
• Last updated: 2025-01-08

Locations

1 site across 1 country: Canada