Alcohol-related Liver DiseaseMYO-SLDNCT06514300
Investigating Myosteatosis in Steatotic Liver Diseases
An observational study of Alcohol-related Liver Disease and Metabolic Dysfunction Associated Steatotic Liver Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-related Liver Disease, Metabolic Dysfunction Associated Steatotic Liver Disease, Steatotic Liver Disease of Mixed Origin (MetALD)
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Jun 2020to Aug 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol-related Liver Disease, Metabolic Dysfunction Associated Steatotic Liver Disease, Steatotic Liver Disease of Mixed Origin (MetALD), Steatotic Liver Diseases, Myosteatosis, Magnetic Resonance Imaging
- Keywords
- myosteatosis, steatotic liver disease, metabolic dysfunction-associated steatotic liver disease, alcohol-related liver disease, MetALD, magnetic resonance imaging, magnetic resonance spectroscopy, liver biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
correlation between muscle mass and fat content and liver histological features of SLD
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.
Measured: MRI and liver biopsy are performed at Day 1
Secondary outcomes (2)
liver molecular mechanisms involved in myosteatosis pathogenesis
mRNA extraction and sequencing from liver tissue samples collected during liver biopsy to assess the transcriptomic pattern correlating with muscle fat assessed by MRI.
Measured: liver samples are collected during the biopsy
impact of muscle fat content on muscle function
investigators assess the correlation between muscle fat assessed by MRI and muscle function assessed by several tests.
Measured: muscle function tests are performed 1-week after the biopsy/MRI (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Jun 2020
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alcohol-related Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, Concerted Research Action
- Responsible party
- Sponsor
- Investigators
- Nicolas Lanthier, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514300
- Sponsor's protocol ID
- ST-IR-01 - MYO-SLD
- Acronym
- MYO-SLD
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linge J, Nasr P, Sanyal AJ, Dahlqvist Leinhard O, Ekstedt M. Adverse muscle composition is a significant risk factor for all-cause mortality in NAFLD. JHEP Rep. 2022 Dec 24;5(3):100663. doi: 10.1016/j.jhepr.2022.100663. eCollection 2023 Mar.
PubMed 36818816Ong JP, Pitts A, Younossi ZM. Increased overall mortality and liver-related mortality in non-alcoholic fatty liver disease. J Hepatol. 2008 Oct;49(4):608-12. doi: 10.1016/j.jhep.2008.06.018. Epub 2008 Jul 9.
PubMed 18682312Singal AK, Mathurin P. Diagnosis and Treatment of Alcohol-Associated Liver Disease: A Review. JAMA. 2021 Jul 13;326(2):165-176. doi: 10.1001/jama.2021.7683.
PubMed 34255003Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.
PubMed 37364790Nachit M, Lanthier N, Rodriguez J, Neyrinck AM, Cani PD, Bindels LB, Hiel S, Pachikian BD, Trefois P, Thissen JP, Delzenne NM. A dynamic association between myosteatosis and liver stiffness: Results from a prospective interventional study in obese patients. JHEP Rep. 2021 Jun 15;3(4):100323. doi: 10.1016/j.jhepr.2021.100323. eCollection 2021 Aug.
PubMed 34355155Nachit M, Kwanten WJ, Thissen JP, Op De Beeck B, Van Gaal L, Vonghia L, Verrijken A, Driessen A, Horsmans Y, Francque S, Leclercq IA. Muscle fat content is strongly associated with NASH: A longitudinal study in patients with morbid obesity. J Hepatol. 2021 Aug;75(2):292-301. doi: 10.1016/j.jhep.2021.02.037. Epub 2021 Apr 15.
PubMed 33865909Henin 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.
PubMed 38322420Henin G, Goffaux A, Declerck S, Andre-Dumont S, Pendeville E, Valet M, Lejeune T, Dahlqvist G, Loumaye A, Schnabl B, Starkel P, Lanthier N. Non-Cirrhotic Steatotic Liver Disease is Associated With Impaired Muscle Function: A Cross-Sectional Study. JCSM Commun. 2025 Jul-Dec;8(2):e70012. doi: 10.1002/rco2.70012. Epub 2025 Oct 7.
PubMed 41127673