Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT06764056

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

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

Full registry 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).

Treatments and study arms

semaglutide

Drug

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.

Diet

Other

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 outcomes

Liver SteatosisFrom enrollment to the end of the clinical trial at 12 months (for 4 visits)

Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic steatosis based on CAP (dB/m) (specific to FibroScan®): S0 (\< 302), S1 (302-331), S2 (331-337) and S3 (\>337).

Liver StiffnessFrom enrollment to the end of the clinical trial at 12 months (for 4 visits)

Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic fibrosis based on liver stiffness (kPa) (specific to FibroScan®): F0-F1 (\< 8.0), F2 (8.9-9.7), F3 (9.7-13.6) and F4 (\>13.6).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval🇨🇦 Québec, Quebec, Canada

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Tristan Rocheleau, RD., Ph.D.(c)Contact

Email · Call 5819969946

Fannie Lajeunesse-Trempe, MD., Ph.D.Contact

André Tchernof, Ph.D.Contact