Health TrialsbyHealthPanel

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

ConditionsMetabolic Associated Fatty Liver DiseaseMetabolic Associated-dysfunction Steatohepatitis (MASH)Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index between 30 and 50 kg/m2;

Stade 2 or 3 (S2 or S3) hepatic steatosis with or without liver fibrosis.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: NutritionActive comparator 1 intervention
Group B: Nutrition + SemaglutideActive comparator 2 interventions
Group C: SemaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Liver Steatosis

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).

Time frame
From enrollment to the end of the clinical trial at 12 months (for 4 visits)
2

Liver Stiffness

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).

Time frame
From enrollment to the end of the clinical trial at 12 months (for 4 visits)

Secondary outcomes

1

Liver function (biochemistry)

Blood samples will be drawn at each visit to assess the following measures: liver enzymes (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], gamma-glutamyl transferase \[GGT\], alkaline phosphatase \[ALP\]), total bilirubin and albumin. Liver scores will also be calculated: fatty liver index (FLI) and fibrosis-4 index (FIB-4) The following normal ranges will be used: * AST : \[8-33\] U/L; * ALT : \[10-40\] U/L; * GGT : \[2-30\] U/L; * ALP : \[30-120\] U/L; * Total bilirubin : \[5-21\] umol/L; * Albumin : \[35-30\] g/L. * FLI : \<30 : Low risk of hepatic steatosis ; \>60 : High risk of hepatic steatosis. * FIB-4 : \>3.48 : High risk of cirrhosis

Time frame
From enrollment to the end of the clinical trial at 12 months (for 4 visits)
2

Lipid panel

Blood samples will be drawn at each visit to assess the lipid panel. The following ranges will be used: * triglycerides: \< 1.5 mmol/L; * total cholesterol: \< 5.20 mmol/L; * LDL-cholesterol: \< 2.59 mmol/L; * HDL-cholesterol: \> 1.55 mmol/L;

Time frame
From enrollment to the end of the clinical trial at 12 months (for 4 visits)
3

Change from Baseline in the gut microbiota diversity

The composition of the gut microbiota will be measured at each visit with the participants' stool samples. The difference between the concentration of gut microbiota diversity (bacteria, families, phyllum, etc.) will be analyzed.

Time frame
From enrollment to the end of the clinical trial at 12 months (for 4 visits)
4

Change from Baseline in blood lipids and metabolites

We will perform lipidomic and metabolomic measures with blood samples of each visit with liquid chromatography coupled with mass spectrometry (LC-MS/MS).

Time frame
From enrollment to the end of the clinical trial at 12 months (for 4 visits)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: