Screening patients at risk for liver disease in Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The GRIPonMASH initiative aims to assist primary healthcare providers in implementing a patient care pathway to identify individuals at risk of metabolic dysfunction-associated steatotic liver disease (MASLD) and its progressive form, metabolic dysfunction-associated steatohepatitis (MASH). This observational study will screen 10,000 high-risk patients across 10 European countries using non-invasive tests such as FIB-4 and FibroScan, alongside blood samples and liver biopsies for further analysis. The study will also explore genomic and metabolic markers to enhance understanding of MASLD and improve patient identification. Participants will be followed for five years to observe the disease's natural progression.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Erasme, Cliniques Universitaires De Bruxelles
  Brussels, Vlaams-brabant, Belgium Recruiting
• Universitätsmedizin Mainz
  Mainz, Rhineland-Palatinate, Germany Recruiting
• Amsterdam UMC
  Amsterdam, South Holland, Netherlands Recruiting
• Franciscus Gasthuis & Vlietland
  Rotterdam, South Holland, Netherlands Recruiting
• ULSSM - Unidade Local de Saúde Santa Maria, E.P.E
  Lisbon, Portugal Recruiting
• Hospital Universitario Virgen del Rocío
  Seville, Spain Recruiting

Study contacts

• Principal investigator: Manuel Castro Cabezas, MD/PhD — Sint Franciscus Gasthuis
• Study coordinator: de Jong
• Email: griponmash@juliusclinical.com
• Phone: +31628259968

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Endoscopic ultrasound shear wave elastography for measuring liver fibrosis

  This study will test whether endoscopic ultrasound shear wave elastography and attenuation imaging can estimate liver fibrosis compared with biopsy and FibroScan in adults with suspected MASLD or MASH.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.