Clinical trial NCT06506513: Targeting the Skeletal Muscle to Treat Metabolic Dysfunction-associated Steatotic Liver Disease
Official title: Targeting Myosteatosis Though Physical Exercise to Treat Metabolic Dysfunction-associated Steatotic Liver Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Concerted Research Action
name: Fonds National de la Recherche Scientifique
First posted: 2024-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the impact of physical activity on muscle and liver phenotypes
timeFrame: every four weeks from baseline till study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Louvain-La-Neuve
country: Belgium
facility: Centre d'investigation clinique en nutrition
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Nicolas Lanthier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.