Clinical trial NCT06764056: Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Official title: Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Associated Fatty Liver Disease
Metabolic Associated-dysfunction Steatohepatitis (MASH)
Obesity
Keywords: Obesity
Metabolic associated fatty liver disease
GLP-1 receptor analogs
Pharmacotherapy
Nutrition
Transient elastography
Semaglutide
Microbiome
Lipidomics
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Body mass index between 30 and 50 kg/m2;
* Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

Exclusion Criteria:

* Type 1 diabetes diagnosis;
* Alcohol consumption exceeding recommendations \[\>140 g/week (women) and \>210 g/week (men)\];
* Known chronic hepatic disease non-steatotic at the entry of the study (Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, viral hepatitis, auto-immune hepatitis, etc.);
* Pharmacological treatment targeting obesity active or ended in the last 3 months;
* Bariatric surgery;
* Gastro-intestinal pathologies (GI cancers, IBD, etc.);
* Capsulated probiotics consumption;
* Antibiotic treatment in the last 3 months;
* Pregnancy;
* Cirrhosis diagnosis (hepatic decompensation).

Primary outcomes:
measure: Liver Steatosis
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Liver Stiffness
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Secondary outcomes:
measure: Liver function (biochemistry)
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Lipid panel
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Change from Baseline in the gut microbiota diversity
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Change from Baseline in blood lipids and metabolites
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Glucose
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Insulin
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Glycated hemoglobin
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: C-reactive protein
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Liver enzymes
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Fatty liver index (FLI)
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
measure: Fibrosis-4 index (FIB-4)
timeFrame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
state: Quebec
Study officials:
affiliation: Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
name: Fannie Lajeunesse-Trempe, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: