By InvitationNot Applicable

Investigating Myosteatosis in Steatotic Liver Diseases

Belgium100 participantsStarted 2020-06-22

Plain-language 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 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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 mo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

correlation between muscle mass and fat content and liver histological features of SLD

Timeframe: MRI and liver biopsy are performed at Day 1

Trial details

NCT IDNCT06514300

SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08

View on ClinicalTrials.gov More Alcohol-related Liver Disease trials