GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.
Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.
Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.
At least 2 times a fasting glucose > 7,0 mmol/L
Or elevated non-fasting glucose >11,1 mmol/L 2 hrs after OGTT
The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);
The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;
The patient engages in (excessive) alcohol use: > 3 units/day in males [30 grams/day] and > 2 units/day in females [20 grams/day];
The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;
Male and female patients aged 18-75 years with a current or prior diagnosis of at least one of the following four conditions: type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension. Subjects who meet the inclusion and exclusion criteria will be enrolled at primary care centers in one of the 10 countries.
Cohort
Prospective
Not listed
Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk
Steatosis grade deduced from controlled attenuation parameter (CAP) measurement with Fibroscan
Prevalence of liver fibrosis estimated by FibroScan LSM in patients at risk
Fibrosis stage deduced from liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) measurement with Fibroscan
Prevalence of at-risk MASH estimated by FAST score in patients at risk
At-risk MASH deduced from FAST score
*Subset of patients: prevalence of MASH in patients at risk
MASH diagnosis confirmed by histology (NAS/SAF criteria) upon liver biopsy; only in patients with \>12 kPa at 1st FibroScan or \>=8 kPa at 2nd FibroScan
Build diagnostic model to identify MASH patients in a high-risk population
Possible model parameters are all baseline clinical characteristics reported in the eCRF
Genotypes related to MASH in different European countries: Exploratory
Genomic (GWAS) and proteomic analysis on collected blood samples
(Non-invasive) metabolite biomarkers identifying MASH in patients at risk: Exploratory
Mass-spectrometry (MS) based metabolomic and lipidomic analyses on collected blood and samples, both targeted and untargeted approaches.
Prevalence of co-morbidities and associated therapies (especially for CVD) in patients with MASH compared to those without, in high-risk patient populations
Prevalence of comorbidities, medication use, medical history
Click on the lead sponsor to view all of their trials.
Julius Clinical
Lead sponsor
UMC Utrecht
Collaborator
Echosens
Collaborator
MIMETAS BV
Collaborator
Nordic Bioscience A/S
Collaborator
Elevate BV
Collaborator
Leiden University
Collaborator
Amsterdam University Medical Center
Collaborator
Andaluz Health Service
Collaborator
National Research Council, Institute of Clinical Physiology, Italy
Collaborator
Leiden University Medical Center
Collaborator
Université Libre de Bruxelles
Collaborator
University Hospital, Antwerp
Collaborator
Catholic University of the Sacred Heart
Collaborator
Medical Education Research And Innovation Center S.R.L.
Collaborator
EUROPEAN LIVER PATIENTS ASSOCIATION
Collaborator
Harokopio University
Collaborator
General University Hospital, Prague
Collaborator
Novo Nordisk A/S
Collaborator
Maastricht University
Collaborator
Mercodia Aktiebolag
Collaborator
EXIT071 BV
Collaborator
European Atherosclerosis Society
Collaborator
MetaDeq Limited
Collaborator
Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Collaborator
Institute of Cardiometabolism and Nutrition, France
Collaborator
University Hospital, Saarland
Collaborator
Roche Pharma AG
Collaborator
Inventiva Pharma
Collaborator
Biocellvia
Collaborator
Franciscus Gasthuis & Vlietland (Hospital)
Collaborator
