About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
13Sponsors and collaborators
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