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

No trial groups listed

Locations

13
Belgium
Hôpital Erasme, Cliniques Universitaires De BruxellesB-1070, BrusselsVlaams-brabant, Belgium
Antwerp University HospitalB-2650, Antwerp Belgium
Czechia
4th internal clinic General University Hospital128 08, PragueBohemia, Czechia
France
Hôpital de la Pitié Salpêtrière75013, ParisIl-de-France, France

Sponsors 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