Investigating Myosteatosis in Steatotic Liver Diseases (MYO-SLD)

July 22, 2024 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

MYO-SLD : a Prospective Study to Determine the Phenotype of Muscle Fat Accumulation in a Cohort of Patients With SLD as to Confirm the Association Between Muscle Composition and Texture and the Phenotype of Liver Disease

Steatotic liver diseases (SLD) are the most common chronic liver diseases worldwide. SLD are defined by an excessive liver lipid content (steatosis) of more than 5% of the total liver weight and includes 3 clinical entities : metabolic dysfunction-associated steatotic liver disease (MASLD), alcohol-related liver disease (ALD) and a mixed entity combining the two settings referred as MetALD. SLD are associated to extra-hepatic complications such as cardiovascular diseases, insulin resistance or muscle changes. Among the latter, myosteatosis, defined by an excessive muscle fat content, has been reported as a muscle change in MASLD occuring even in non-cirrhotic stages. Investigators will explore these muscle changes in SLD patients according to the severity of the underneath liver disease.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

This project investigates the correlation between liver and muscle phenotypes assessed in a cohort of all 3 SLD subgroups (MASLD, ALD and MetALD). If a severe form of SLD is suspected based on a severely increased liver elasticity, assessed by transient elastography, participants undergo a liver biopsy, liver and muscle magnetic resonance imaging. Eating habits and physical activity level are recorded using the 24 hour-recall and international physical activity questionnaire. Psychological disorders are also screened using dedicated questionnaires.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This study is intended for patients with steatotic liver diseases SLD) characterized by an excessive liver lipid content higher than 5% (steatosis). SLD include 3 clinical entities with specific diagnostic criteria previously defined (Rinella MC, et al. J Hepatol. 2023) : metabolic dysfunction-associated steatotic liver disease, highly related to overweight, obesity and type 2 diabetes; alcohol-related liver disease, secondary to an excessive alcohol beverages consumption; and a third mixed entity combining both conditions called MetALD. All SLD patients will be recruited in this project to investigate if muscle phenotype is specifically related to one type of SLD.

Description

Inclusion Criteria:

  • Age between18 to 75 years
  • Presence of hepatic steatosis, suggested by a controlled attenuation parameter (CAP) ≥ 252 dB/m on elastometry and elevated transaminases (ALT ≥ 25 or 33 IU/L in women or men respectively)
  • Presence of overweight (BMI > 25 kg/m²), obesity (BMI > 30 kg/m²), metabolic syndrome, prediabetes or type 2 diabetes. Metabolic syndrome is defined by int ernational Diabetes Federation as follows : waist circumference ≥ 94/80cm for men/women with ≥ 2 other criteria: arterial pressure ≥ 130/85 mmHg or treatment for hypertension, fasting glucose ≥ 130/85 mmHg or treatment for hypertension, serum triglycerides > 150 mg/dl or treatment for dyslipidemia, HDL cholesterol < 40/50 mg/dl for men/women or treatment for dyslipidemia.

Exclusion Criteria:

  • Liver disease from other causes (alcohol, active viral chronic hepatitis B or C, Wilson's disease, autoimmune hepatitis, alpha1-anti-trypsin deficiency,...)
  • Heavy consumption of alcoholic beverages, i.e. > 140 g or 210 g of ethanol in women or men respectively).
  • Intravenous drug use
  • HbA1C > 10%
  • Decompensated cirrhosis (presence of ascites, bilirubin level > 1.2 mg/dL in a patient without Gilbert's syndrome, albumin level < 35 g/L)
  • Pregnancy
  • Use of drugs that may cause steatosis (methotrexate, amiodarone, tamoxifen, oral corticosteroids) currently or in the last 3 months
  • Change in treatment of hyperglycaemia (dose or medication) in the last 3 months
  • Change in body weight >5% in the last 3 months
  • Active cancer
  • End stage renal disease or dialysis
  • Type 1 diabetes or secondary diabetes
  • Digestive malabsorption
  • Untreated thyroid disease
  • Taking a treatment under study or approved for NASH (semaglutide, lanifibranor, obeticholic acid).
  • Musculoskeletal disorders, neuromuscular or inflammatory diseases such as connective tissue diseases, myositis and vasculitis that have musculoskeletal manifestations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MASLD patients
patients presenting with liver steatosis and at least one cardiometabolic criteria.
ALD patients
patients presenting with liver steatosis secondary to an excessive consumption of alcoholic beverages and with no cardiometabolic criteria.
MetALD patients
patients presenting with liver steatosis, at least one cardiometabolic criteria and an excessive consumption of alcohol beverages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between muscle mass and fat content and liver histological features of SLD
Time Frame: MRI and liver biopsy are performed at Day 1
muscle mass and fat content will be assessed by magnetic resonance imaging and spectroscopy. Liver phenotype will be histologically assessed by 3 blinded pathologists and computer-assisted morphometry.
MRI and liver biopsy are performed at Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver molecular mechanisms involved in myosteatosis pathogenesis
Time Frame: liver samples are collected during the biopsy
mRNA extraction and sequencing from liver tissue samples collected during liver biopsy to assess the transcriptomic pattern correlating with muscle fat assessed by MRI.
liver samples are collected during the biopsy
impact of muscle fat content on muscle function
Time Frame: muscle function tests are performed 1-week after the biopsy/MRI (Day 7)
investigators assess the correlation between muscle fat assessed by MRI and muscle function assessed by several tests.
muscle function tests are performed 1-week after the biopsy/MRI (Day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Fonds National de la Recherche Scientifique
Concerted Research Action

Investigators

  • Principal Investigator: Nicolas Lanthier, MD, PhD, Cliniques Universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-IR-01 - MYO-SLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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