Taking people in SpainNo phase

Screening for liver disease in primary care patients across Europe

Studies a care pathway to find people with fatty liver disease early in clinics.

Key facts

Who runs it: Julius Clinical
Where: Seville, SpainSee the siteAlso in 9 other countries, 12 sites
Trial code: NCT05651724
Registry title: Global Research Initiative for Patients Screening on MASH
Status: Recruiting
People taking part: 10,000 people, planned
Started: 30 Jun 2023
Expected to end: 31 Mar 2031
Type of study: Observational
Record updated: 1 August 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes, obesity, metabolic syndrome or high blood pressure, to find out who may have fatty liver disease (MASLD or MASH).

Age: 18 to 75 years
Sex: All sexes can join.
Disease stage: People with type 2 diabetes, obesity, metabolic syndrome or arterial hypertension, newly diagnosed or already treated, based on the study definitions. No liver disease stage is required.
Earlier treatment: People already treated for one of these conditions must have had a prior diagnosis that fits the study definitions. People who had weight-loss (bariatric) surgery in the last 12 months cannot join.
Biomarker or test result: The study definitions use test values: for example fasting glucose above 7,0 mmol/L (126 mg/dL), HbA1c of 48 mmol/mol (6.5%) or more, BMI above 30, blood pressure of 140/90 mmHg or more.

Main reasons for not taking part

Known hepatitis B, hepatitis C, HIV or any other liver condition
Any other condition that may lead to liver fibrosis or cirrhosis
Heavy alcohol use: more than 3 units a day for men, more than 2 units a day for women
Pregnant or breastfeeding
Weight-loss (bariatric) surgery in the last 12 months

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

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)

Who cannot take part

The patient underwent bariatric surgery in the last 12 months
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 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 engages in (excessive) alcohol use: > 3 units/day in males [30 grams/day] and > 2 units/day in females [20 grams/day]
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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in Spain

Also in 9 other countries, 12 sites

Hospital Universitario Virgen del RocioSeville, SpainContact: de JongTaking people

About the trial

What the trial wants to find out

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.