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

Launched by INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC, UNIVERSITY LAVAL · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to improve treatment for a condition called Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD), which is often linked to obesity. The researchers want to find out if a personalized nutrition plan created by a dietitian, combined with a medication for obesity called Semaglutide, is the best way to treat fatty liver disease. Participants in the trial will be divided into three groups: one group will only meet with a dietitian, another group will receive Semaglutide along with dietitian support, and the last group will receive only Semaglutide.

To be eligible for the trial, participants should have a body mass index (BMI) between 30 and 50 and have moderate to severe fatty liver disease. However, people with certain health conditions, like Type 1 diabetes or significant liver disease, or those who have recently undergone weight loss surgery, are not eligible. The trial is not yet recruiting participants, but once it starts, those who join can expect regular check-ins with a dietitian and possibly medication, depending on which group they are placed in. This study aims to better understand how to manage and treat fatty liver disease effectively in individuals with obesity.

Gender

ALL

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).