Status:
ENROLLING_BY_INVITATION
Investigating Myosteatosis in Steatotic Liver Diseases
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Fonds National de la Recherche Scientifique
Concerted Research Action
Conditions:
Alcohol-related Liver Disease
Metabolic Dysfunction Associated Steatotic Liver Disease
Eligibility:
All Genders
18-75 years
Brief 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 inclu...
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 sever...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
June 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06514300
Start Date
June 22 2020
End Date
August 1 2024
Last Update
July 23 2024
Active Locations (1)
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1
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200