RecruitingOBSERVATIONAL

Global Research Initiative for Patients Screening on MASH

The GRIPonMASH study wants to help doctors in primary care across Europe better identify patients at risk of serious liver problems like MASLD and MASH. These conditions are linked with other common health issues such as type 2 diabetes, obesity, and high blood pressure. The study focuses on using the latest care guidelines from experts to ensure that people who might have these liver diseases are found early and receive appropriate care. This involves screening over 10,000 people who have these linked health conditions using special tests. The main goal is to put in place a clear pathway for patient care, making it easier to spot and understand these liver conditions in communities across 10 European countries.

At a glance

Status

Recruiting

Sponsor

Julius Clinical

Enrolment target

10,000

Start

30 Jun 2023

Estimated completion

31 Mar 2031

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

What is this study about?

The GRIPonMASH study is a big project happening across 10 European countries. Its main goal is to help local doctors and nurses better find and understand liver conditions like Metabolic Dysfunction-Associated Steatosis Liver Disease (MASLD) and its more serious form, Metabolic Dysfunction-Associated Steatohepatitis (MASH). These liver conditions are often found in people who also have other health issues like type 2 diabetes, obesity, high blood pressure, or a combination of these, known as metabolic syndrome.

The study aims to put into practice the newest recommendations from leading liver experts (the European Association for the Study of the Liver). This means creating a smooth system for patient care, from your local doctor's office to specialist clinics, to make sure that people at risk are identified early. By doing this, the study hopes to raise awareness among both healthcare providers and patients about these important liver diseases.

To achieve this, researchers will look at 10,000 patients who have these linked health conditions. They’ll use a combination of simple tests, like blood tests and a special scan called FibroScan, to check for MASLD and scarring in the liver (fibrosis). They will also collect blood and sometimes small liver tissue samples to learn more about how these diseases develop. This deeper understanding will help them find better ways to spot people at risk in the future and follow their health over five years to see how the disease progresses naturally.

Key takeaways

The study aims to help doctors find serious liver conditions like MASH earlier.
It targets people with health problems such as type 2 diabetes, obesity, or high blood pressure.
Participation involves non-invasive tests like blood tests and a liver scan (FibroScan).
It's an observational study, meaning no new medicines will be given, but your health will be monitored.
The study will follow participants for five years to understand the disease better.
Your involvement could help improve care for future patients with liver disease.

Who may be eligible?

This study is looking for adults aged 18 to 75 years old. You might be able to join if you have been diagnosed with type 2 diabetes, obesity, high blood pressure, or metabolic syndrome, or if you are currently receiving treatment for any of these conditions.

Specifically, for type 2 diabetes, this means your blood sugar levels are consistently high, or you're being treated for it. For obesity, it means your Body Mass Index (BMI) is over 30, or your waist measurement is above certain limits depending on your background. For high blood pressure, it means your blood pressure readings are consistently high, or you are on medication for it.

You cannot take part if you are known to have other liver conditions like hepatitis B, hepatitis C, or HIV.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have type 2 diabetes, obesity, high blood pressure, or metabolic syndrome?
Are you currently being treated for any of these conditions?
Do you NOT have hepatitis B, hepatitis C, or HIV?
Do you understand this is an observational study, not a treatment trial?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new medications or treatments. This is an 'observational' study, meaning researchers will monitor your health and gather information about your existing conditions and liver health over time. You will undergo some screenings, which typically involve blood tests (like the FIB-4 test) and a special non-invasive liver scan called FibroScan. You might also have other unproven non-invasive tests as part of the research.

Some participants may also be asked to provide additional samples, such as more detailed blood tests or, in some cases, a small liver tissue sample (biopsy), though this will be discussed with you thoroughly if needed. Researchers will use these samples to understand the disease better at a genetic and molecular level. All participants will be followed for a long term of five years to see how their health and liver condition changes over time. The exact number of visits will depend on the study's protocol, but the follow-up is designed to observe your natural disease progression.

Potential risks and benefits

Participating in this study will not involve new treatments, so there's no direct medical benefit in terms of receiving a new therapy. However, learning more about your liver health through tests like blood work and FibroScan could lead to an earlier diagnosis of MASLD or MASH, allowing for earlier management by your doctor. The main benefit is contributing to a better understanding of these common liver diseases, which could help future patients. Risks are generally low; blood tests carry minor risks like bruising, and a FibroScan is non-invasive and safe. If a liver biopsy is suggested, there are small risks associated with any medical procedure, which would be fully explained before you decide. Remember, you can choose to withdraw from the study at any time without affecting your usual medical care.

Locations (13)

Hôpital Erasme, Cliniques Universitaires De Bruxelles
Verified postcode
Brussels, Belgium· Recruiting
Antwerp University Hospital
Verified postcode
Antwerp, Belgium· Active not recruiting
4th internal clinic General University Hospital
Verified postcode
Prague, Czechia· Not yet recruiting
Hôpital de la Pitié Salpêtrière
Verified postcode
Paris, France· Not yet recruiting
Universitätsmedizin Mainz
Verified postcode
Mainz, Germany· Recruiting
Universitätsklinikum des Saarlandes
Verified postcode
Homburg, Germany· Not yet recruiting
Harokopio University of Athens
Verified postcode
Athens, Greece· Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)
Verified postcode
Rome, Italy· Not yet recruiting
Amsterdam UMC
Approximate
Amsterdam, Netherlands· Recruiting
Franciscus Gasthuis & Vlietland
Verified postcode
Rotterdam, Netherlands· Recruiting
ULSSM - Unidade Local de Saúde Santa Maria, E.P.E
Verified postcode
Lisbon, Portugal· Recruiting
Sacele Municipal Hospital
Verified postcode
Săcele, Romania· Not yet recruiting

Common questions

What is MASH?

MASH stands for Metabolic Dysfunction-Associated Steatohepatitis. It's a more serious type of fatty liver disease that can lead to liver damage and scarring.

What is MASLD?

MASLD means Metabolic Dysfunction-Associated Steatosis Liver Disease. It's a condition where too much fat builds up in the liver, often linked with conditions like diabetes and obesity.

What is a FibroScan?

A FibroScan is a quick, non-invasive test that uses sound waves to measure liver stiffness and fat content, helping doctors check for liver scarring or fatty liver.

Will I receive new treatment in this study?

No, this is an observational study. You will not receive any new treatments, but researchers will gather information about your liver health.

How long will I be in the study?

If you participate, you will be followed for a long term, over a period of five years.

How to find out more

de Jong

griponmash@juliusclinical.com +31628259968 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.