Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease

NCT ID: NCT06506513

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metabolic Dysfunction-associated Steatotic Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients presenting both MASLD and an excessive muscle lipid content (myosteatosis) assessed by magnetic resonance imaging will be recruited. All patients will then be randomized in three groups corresponding to three physical activity programs of increasing intensity.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

in this control group, patients will perform non-cardiovascular non-intensity training (stretching, meditation).

Group Type ACTIVE_COMPARATOR

Low intensity exercise training

Intervention Type OTHER

Low intensity exercise training

moderate-intensity low interval training group

In this group, patients will perform moderate-intensity low interval training.

Group Type ACTIVE_COMPARATOR

Moderate intensity exercise training

Intervention Type OTHER

Moderate intensity exercise training

high-intensity interval training

In this group, patients willp erform high-intensity interval training.

Group Type ACTIVE_COMPARATOR

High-intensity interval training

Intervention Type OTHER

High-intensity interval training

Interventions

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High-intensity interval training

High-intensity interval training

Intervention Type OTHER

Moderate intensity exercise training

Moderate intensity exercise training

Intervention Type OTHER

Low intensity exercise training

Low intensity exercise training

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Concerted Research Action

UNKNOWN

Sponsor Role collaborator

Fonds National de la Recherche Scientifique

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Lanthier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Centre d'investigation clinique en nutrition

Louvain-la-Neuve, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Guillaume Henin, MD, PhD student

Role: CONTACT

0032494312548

Nicolas Lanthier, MD, PhD

Role: CONTACT

003227647089

Facility Contacts

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Guillaume Henin, MD, PhD student

Role: primary

0032494312548

Nicolas Lanthier, MD, PhD

Role: backup

003227647089

Guillaume Henin, MD, PhD student

Role: primary

louise Deldicque, PhD

Role: backup

References

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Henin G, Loumaye A, Leclercq IA, Lanthier N. Myosteatosis: Diagnosis, pathophysiology and consequences in metabolic dysfunction-associated steatotic liver disease. JHEP Rep. 2023 Nov 14;6(2):100963. doi: 10.1016/j.jhepr.2023.100963. eCollection 2024 Feb.

Reference Type RESULT
PMID: 38322420 (View on PubMed)

Henin G, Loumaye A, Deldicque L, Leclercq IA, Lanthier N. Unlocking liver health: Can tackling myosteatosis spark remission in metabolic dysfunction-associated steatotic liver disease? Liver Int. 2024 Aug;44(8):1781-1796. doi: 10.1111/liv.15938. Epub 2024 Apr 16.

Reference Type RESULT
PMID: 38623714 (View on PubMed)

Other Identifiers

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ST-IR-01 MYO-MASLD

Identifier Type: -

Identifier Source: org_study_id

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