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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Liver Steatosis — From 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 Stiffness — From 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).
Trial sites (1)
Facility
City
Region
Status
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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