Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease (MYO-MASLD)

July 11, 2024 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Targeting Myosteatosis Though Physical Exercise to Treat Metabolic Dysfunction-associated Steatotic Liver Disease

Muscle changes including myosteatosis are reported as highly prevalent in metabolic dysfunction-associated steatotic liver disease (MASLD). Recent studies highlighted a link between muscle fat content and liver disease severity. Conversely, MASLD histological remission though diet or metabolic surgeries is also linked to a decrease in muscle fat content. Therefore, skeletal muscle appears as a potential target to treat MASLD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this monocenter interventional study, we will assess the impact of physical activity on muscle fat content and liver disease severity in MASLD as well as the mechanisms mediating the potential beneficial effects of exercise.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques universitaires Saint-Luc
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolas Lanthier, MD, PhD
        • Sub-Investigator:
          • Audrey Loumaye, MD, PhD
      • Louvain-La-Neuve, Belgium, 1348
        • Centre d'investigation clinique en nutrition
        • Contact:
          • Guillaume Henin, MD, PhD student
        • Contact:

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

Description

Inclusion Criteria:

  • confirmed MASLD at abdominal imaging
  • confirmed excessive muscle lipid content at imaging
  • stable weight

Exclusion Criteria:

  • severe comorbidities including active malignancies, neuromuscular degenerative diseases
  • contraindications to physical activity
  • excessive alcohol consumption

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
in this control group, patients will perform non-cardiovascular non-intensity training (stretching, meditation).
Other: Low intensity exercise training
Low intensity exercise training
Active Comparator: moderate-intensity low interval training group
In this group, patients will perform moderate-intensity low interval training.
Other: Moderate intensity exercise training
Moderate intensity exercise training
Active Comparator: high-intensity interval training
In this group, patients willp erform high-intensity interval training.
Other: High-intensity interval training
High-intensity interval training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the impact of physical activity on muscle and liver phenotypes
Time Frame: every four weeks from baseline till study completion
the investigators will assess at baseline and every four weeks till study completion the impact of intervention on liver phenotype assessed by transient elastography and muscle phenotype assessed by MRI
every four weeks from baseline till study completion

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 11, 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-MASLD

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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