Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT05651724

Global Research Initiative for Patients Screening on MASH

Led by Julius Clinical · Updated on 2024-08-01

10000

Participants Needed

13

Research Sites

404 weeks

Total Duration

On this page

Sponsors

J

Julius Clinical

Lead Sponsor

U

UMC Utrecht

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Global Research Initiative for Patients Screening on MASH

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed with type 2 diabetes mellitus, metabolic syndrome, obesity, or arterial hypertension according to study definitions
  • Currently treated for type 2 diabetes mellitus, metabolic syndrome, obesity, or arterial hypertension with prior diagnosis
  • For type 2 diabetes mellitus: fasting glucose > 7.0 mmol/L at least twice, or elevated non-fasting glucose > 11.1 mmol/L 2 hours after OGTT, or HbA1c 48 mmol/mol (6.5%), or active treatment for previously diagnosed type 2 diabetes
  • For obesity: body mass index (BMI) > 30, or waist circumference meeting specific thresholds by ethnicity and gender
  • For arterial hypertension: systolic BP 140 mmHg and/or diastolic BP 90 mmHg, or active treatment for previously diagnosed hypertension
  • For metabolic syndrome: central obesity by waist circumference or BMI > 30, plus at least two of raised triglycerides, reduced HDL cholesterol, raised blood pressure, or raised fasting plasma glucose according to defined thresholds
Not Eligible

You will not qualify if you...

  • Known hepatitis B, hepatitis C, HIV, or other liver conditions such as hemochromatosis, sarcoidosis, or Wilson's disease
  • Known conditions causing liver fibrosis or cirrhosis
  • Excessive alcohol use: more than 3 units/day for males or more than 2 units/day for females
  • History or evidence of other significant medical conditions or planned procedures that may affect safety or study participation
  • Employment or family relationship to study investigators or sponsor personnel
  • Inability to understand protocol details or provide written informed consent
  • Pregnancy or breastfeeding
  • Bariatric surgery within the last 12 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 13 locations

1

Hôpital Erasme, Cliniques Universitaires De Bruxelles

Brussels, Vlaams-brabant, Belgium, B-1070

Actively Recruiting

2

Antwerp University Hospital

Antwerp, Belgium, B-2650

Active, Not Recruiting

3

4th internal clinic General University Hospital

Prague, Bohemia, Czechia, 128 08

Not Yet Recruiting

4

Hôpital de la Pitié Salpêtrière

Paris, Il-de-France, France, 75013

Not Yet Recruiting

5

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany, 55131

Actively Recruiting

6

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany, 66421

Not Yet Recruiting

7

Harokopio University of Athens

Athens, Greece, 17676

Not Yet Recruiting

8

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)

Rome, Lazio, Italy, 00168

Not Yet Recruiting

9

Amsterdam UMC

Amsterdam, South Holland, Netherlands, 1105 AZ

Actively Recruiting

10

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands, 3045 PM

Actively Recruiting

11

ULSSM - Unidade Local de Saúde Santa Maria, E.P.E

Lisbon, Portugal, 1649-028

Actively Recruiting

12

Sacele Municipal Hospital

Săcele, Brașov County, Romania, 505600

Not Yet Recruiting

13

Hospital Universitario Virgen del Rocío

Seville, Spain, 41013

Actively Recruiting

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Research Team

D

de Jong

CONTACT

W

Wijkhuis

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Global Research Initiative for Patients Screening on MASH | DecenTrialz