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NCT Number: NCT06764056

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

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.

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Key information

Conditions

Metabolic Associated Fatty Liver Disease Body Weight Metabolic Associated-dysfunction Steatohepatitis (MASH) Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

Location contact

André Marette, Ph.D.

CONTACT

André Tchernof, Ph.D.

CONTACT

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

CONTACT

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

CONTACT

[email protected]

5819969946

About this study

Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.

The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Individualized nutritionnal intervention, Nutritionnal counselling

Primary outcomes

  1. Liver Steatosis

    Time frame: 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).

  2. Liver Stiffness

    Time frame: 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).

Secondary outcomes

  1. Liver function (biochemistry)

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

    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

  2. Lipid panel

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

    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;

  3. Change from Baseline in the gut microbiota diversity

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

    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.

  4. Change from Baseline in blood lipids and metabolites

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

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

  5. Glucose

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

    Blood samples will be drawn at each visit to assess the glucose.

    The following range will be used:

    • glucose: < 5.6 mmol/L;

  6. Insulin

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

    Blood samples will be drawn at each visit to assess insulin

    The following range will be used:

    • insuline: [20-60] pmol/L;

  7. Glycated hemoglobin

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

    Blood samples will be drawn at each visit to assess HbA1c

    The following range will be used:

    • HbA1c: < 6.5 %;

  8. C-reactive protein

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

    Blood samples will be drawn at each visit to assess the c-reactive protein

    The following range will be used:

    • CRP: < 10 mg/L.

  9. Liver enzymes

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

    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] and alkaline phosphatase [ALP]),

    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.

  10. Fatty liver index (FLI)

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

    The Fatty liver index (FLI) is a non-invasive score to calculate liver steatosis (using BMI, WC, TG and GGT).

    The following ranges will be used:

    • <30 : Low risk of hepatic steatosis ;
    • >60 : High risk of hepatic steatosis.

  11. Fibrosis-4 index (FIB-4)

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

    The fibrosis-4 index (FIB-4) is a non-invasive score to calculate liver fibrosis (using Age, AST, ALT and Platelet count).

    The following normal range will be used:

    • <30 : Low risk of hepatic steatosis ; >60 : High risk of hepatic steatosis. fatty liver index (FLI) and

    The following range will be used:

    • FIB-4 : >3.48 : High risk of cirrhosis

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

418-656-8711, #8052

Tristan Rocheleau, RD., M.Sc.

CONTACT

[email protected]

418-656-8711, #2681

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Characterization and Management of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Through an Individualized Nutritionnal Approach and Semaglutide Therapy.

Acronym: METAfoie

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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