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

NCT06506513 | Not Yet Recruiting

• 1 other identifier: ST-IR-01 MYO-MASLD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

metabolic dysfunction-associated steatotic liver disease; MASLD; physical activity; myosteatosis; magnetic resonance imaging; magnetic resonance specroscopy; muscle biopsy

Outcome Measures

Primary Outcomes (1)

• the impact of physical activity on muscle and liver phenotypes

  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

Study Arms (3)

control group

ACTIVE COMPARATOR

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

Other: Low intensity exercise training

moderate-intensity low interval training group

ACTIVE COMPARATOR

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

Other: Moderate intensity exercise training

high-intensity interval training

ACTIVE COMPARATOR

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

Other: High-intensity interval training

Interventions

High-intensity interval training OTHER

High-intensity interval training

high-intensity interval training

Moderate intensity exercise training OTHER

Moderate intensity exercise training

moderate-intensity low interval training group

Low intensity exercise training OTHER

Low intensity exercise training

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• Concerted Research Action: collaborator
• Fonds National de la Recherche Scientifique: collaborator

Study Sites (2)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Centre d'investigation clinique en nutrition

Louvain-la-Neuve, 1348, Belgium

Location

Related Publications (2)

• 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.

  PMID: 38322420 RESULT

• 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.

  PMID: 38623714 RESULT

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nicolas Lanthier, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Henin, MD, PhD student

CONTACT

0032494312548; guillaume.henin@uclouvain.be

Nicolas Lanthier, MD, PhD

CONTACT

003227647089; nicolas.lanthier@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 17, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)