NCT06764056Not yet recruiting
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)
Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.
Source: ClinicalTrials.gov · Last updated 8 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 18 Dec 2024
- Start date
- Jan 2025
- Primary completion date
- May 2026
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06764056
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Jan 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bariatric surgery;
Other illness
- Type 1 diabetes diagnosis;
- 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.);
- Gastro-intestinal pathologies (GI cancers, IBD, etc.);
Other
- Alcohol consumption exceeding recommendations \[\>140 g/week (women) and \>210 g/week (men)\];
- Pharmacological treatment targeting obesity active or ended in the last 3 months;
- Capsulated probiotics consumption;
- Antibiotic treatment in the last 3 months;
- Pregnancy;
- Cirrhosis diagnosis (hepatic decompensation).
Who the study is looking for
- Body mass index between 30 and 50 kg/m2;
- Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.