Global Research Initiative for Patients Screening on MASH

Recruiting now

Conditions studied: MASH, MASLD, MASH With Fibrosis, Fibrosis, Liver, Steatosis of Liver, Type 2 Diabetes, Obesity, Metabolic Syndrome, Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT05651724

Run by

Julius Clinical

People needed

10000

Starts

2023-06-30

Expected to finish

2031-03-31

Last updated by the study team

2024-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Hôpital Erasme, Cliniques Universitaires De Bruxelles — Brussels, Vlaams-brabant, Belgium (enrolling)
• Universitätsmedizin Mainz — Mainz, Rhineland-Palatinate, Germany (enrolling)
• Amsterdam UMC — Amsterdam, South Holland, Netherlands (enrolling)
• Franciscus Gasthuis & Vlietland — Rotterdam, South Holland, Netherlands (enrolling)
• ULSSM - Unidade Local de Saúde Santa Maria, E.P.E — Lisbon, Portugal (enrolling)
• Hospital Universitario Virgen del Rocío — Seville, Spain (enrolling)
• Harokopio University of Athens — Athens, Greece
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC) — Rome, Lazio, Italy
• Antwerp University Hospital — Antwerp, Belgium
• 4th internal clinic General University Hospital — Prague, Bohemia, Czechia
• Hôpital de la Pitié Salpêtrière — Paris, Il-de-France, France
• Sacele Municipal Hospital — Săcele, Brașov County, Romania
• Universitätsklinikum des Saarlandes — Homburg, Saarland, Germany

Full record on ClinicalTrials.gov

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