Metabolic dysfunction- and alcohol-associated liver disease, MetALD Liver damage due to metabolic problems and alcohol consumption
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age >18 years of ageDiagnosis: metabolic and alcohol related steatotic liver disease (metALD), based on the following diagnostic criteria:Moderate alcohol consumption, defined as: Self-reported daily intake of 20 to 50 g of alcohol (or weekly 140-350 g) for females and 30 to 60 g daily for males (or weekly 210-420 g) ORSerum phosphatidylethanol (PEth) < 20 ng/mL Meeting criteria of MASLD:Presence of hepatic steatosis based on imaging (ultrasound) or on biopsy or on Fibroscan Prescence of at least one cardiometabolic risk factor:Overweight or obesity, defined as:BMI = 25 kg/m2 Waist circumference =94 cm in men and =80 cm in womenPrediabetes, type 2 diabetes or treatment for type 2 diabetesElevated plasma triglycerides or lipid-lowering treatmentElevated HDL-cholesterol or lipid-lowering treatment Hypertension or treatment for hypertension
Exclusion criteria
Exclusion criteria: Other cause of hepatic steatosis or cirrhosis (e.g. auto-immune hepatitis, hemochromatosis, hepatitis B and or/C, Wilsons disease, alpha-1-antitripsine deficiency)Diagnosis of hepatocellular carcinomaUse of methotrexate, tamoxifen or stavudine/zidovudine/didanosine (i.e. drugs known to aggravate or induce steatotic liver disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histopathological disease progression and (all-cause and liver-related) mortality in metALD patyients over a 5 year period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To apply a systems biology approach by integrating single nucleus RNA sequencing of liver tissue, gut microbiome profiling, and circulating metabolic markers to identify key molecular and cellular mechanisms driving the progression of metALD to advanced disease stages or mortality, over a five-year period. This integrative analysis aims to uncover hierarchical disease-driving pathways and novel therapeutic targets for future treatment strategies in metALD. | — |
Countries
Netherlands
Contacts
Amsterdam UMC