Recruiting
Global Research Initiative for Patients Screening on MASH
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…
ClinicalTrials.gov IDNCT05651724
PhaseNot Applicable
Enrollment10000
SponsorJulius Clinical
Age18 Years – 75 Years
SexALL
About this study
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.
Primary outcomes
- Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk (Baseline)
- Prevalence of liver fibrosis estimated by FibroScan LSM in patients at risk (Baseline)
- Prevalence of at-risk MASH estimated by FAST score in patients at risk (Baseline)
- *Subset of patients: prevalence of MASH in patients at risk (16 or 30 weeks)
- Comparison of the prevalence of MASLD, liver fibrosis and (at-risk) MASH between the participating countries (Baseline (1-3) to 16/30 weeks for biopsy-confirmed MASH (4))
- Evaluate added value of a 2-step pathway as compared to FibroScan only for detection of high-risk patients (Baseline)
Eligibility information
Inclusion Criteria:
* 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.
Study definitions:
Type 2 diabetes mellitus
* At least 2 times a fasting glucose \> 7,0 mmol/L
* Or elevated non-fasting glucose \>11,1 mmol/L 2 hrs after OGTT
* Or HbA1c ≥48 mmol/mol (≥6.5%)
* Or being actively treated for previously diagnosed type 2 diabetes by a health care provider
Obesity
* Body mass index (BMI) \> 30
* Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian/Chinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm
Arterial hypertension
* Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg
* Or being actively treated for previously diagnosed arterial hypertension by a health care provider
Metabolic syndrome
\- Central obesity defined as waist circumference (see above), if BMI is \>30 kg/m2, central obesity can be assumed and waist circumference does not need to be measured
AND any two of the following:
* Raised triglycerides: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality
* Reduced HDL cholesterol: \< 40 mg/dL (1.03 mmol/L) in males, \< 50 mg/dL (1.29 mmol/L) in females, or specific treatment for this lipid abnormality
* Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension
* Raised fasting plasma glucose (FPG): FGP ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (if above \>5.6 mmol/L or 100 mg/dL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)
Exclusion Criteria:
* 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;
* The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;
* The patient is not able to understand the details of the protocol and/or is not able to provide written informed consent;
* The patient is pregnant or breastfeeding.
* The patient underwent bariatric surgery in the last 12 months.
Study locations
- Hôpital Erasme, Cliniques Universitaires De Bruxelles, Brussels, Vlaams-brabant B-1070 Belgium
- Antwerp University Hospital, Antwerp, B-2650 Belgium
- 4th internal clinic General University Hospital, Prague, Bohemia 128 08 Czechia
- Hôpital de la Pitié Salpêtrière, Paris, Il-de-France 75013 France
- Universitätsmedizin Mainz, Mainz, Rhineland-Palatinate 55131 Germany
- Universitätsklinikum des Saarlandes, Homburg, Saarland 66421 Germany
- Harokopio University of Athens, Athens, 17676 Greece
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC), Rome, Lazio 00168 Italy
- Amsterdam UMC, Amsterdam, South Holland 1105 AZ Netherlands
- Franciscus Gasthuis & Vlietland, Rotterdam, South Holland 3045 PM Netherlands
Showing 10 of 13 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.