Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: semaglutide, Diet.
- Who it may be relevant to
- Registry conditions: Metabolic Associated Fatty Liver Disease, Metabolic Associated-dysfunction Steatohepatitis (MASH), Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Liver Steatosis [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Liver Stiffness [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
Secondary outcome measures (11)
- Liver function (biochemistry) [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Lipid panel [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Change from Baseline in the gut microbiota diversity [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Change from Baseline in blood lipids and metabolites [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Glucose [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Insulin [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Glycated hemoglobin [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- C-reactive protein [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Liver enzymes [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Fatty liver index (FLI) [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
- Fibrosis-4 index (FIB-4) [Time frame: From enrollment to the end of the clinical trial at 12 months (for 4 visits)]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec — Québec
Identifiers
NCT: NCT06764056 · 2025-4271