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AMALY

Deciphering disease progression in metALD through multimodal phenotyping and identifying non-invasive biomarkers – Amsterdam metALD Registry (AMALY) study’ - AMALY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON61277
Enrollment
300
Registered
2025-12-16
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic dysfunction- and alcohol-associated liver disease, MetALD Liver damage due to metabolic problems and alcohol consumption

Interventions

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Histopathological disease progression and (all-cause and liver-related) mortality in  metALD patyients over a 5 year period. 

Secondary

MeasureTime 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

Public ContactJ.P.H. Drenth

Amsterdam UMC

a.s.meijnikman@amsterdamumc.nl0645244435

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026