Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway

Status: Recruiting
Location: See all (12) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
Antwerp University Hospital
ACTIVE_NOT_RECRUITING
Antwerp
Hôpital Erasme, Cliniques Universitaires De Bruxelles
RECRUITING
Brussels
France
Hôpital de la Pitié Salpêtrière
NOT_YET_RECRUITING
Paris
Germany
Universitätsklinikum des Saarlandes
NOT_YET_RECRUITING
Homburg
Universitätsmedizin Mainz
RECRUITING
Mainz
Greece
Harokopio University of Athens
NOT_YET_RECRUITING
Athens
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)
NOT_YET_RECRUITING
Rome
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Portugal
ULSSM - Unidade Local de Saúde Santa Maria, E.P.E
RECRUITING
Lisbon
Romania
Sacele Municipal Hospital
NOT_YET_RECRUITING
Săcele
Spain
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Contact Information
Primary
de Jong
griponmash@juliusclinical.com
+31628259968
Backup
Wijkhuis
griponmash@juliusclinical.com
Time Frame
Start Date: 2023-06-30
Estimated Completion Date: 2031-03-31
Participants
Target number of participants: 10000
Sponsors
Collaborators: EXIT071 BV, Catholic University of the Sacred Heart, MetaDeq Limited, Echosens, European Atherosclerosis Society, Biocellvia, Université Libre de Bruxelles, Elevate BV, National Research Council, Institute of Clinical Physiology, Italy, Leiden University Medical Center, EUROPEAN LIVER PATIENTS ASSOCIATION, General University Hospital, Prague, Institute of Cardiometabolism and Nutrition, France, Associação para Investigação e Desenvolvimento da Faculdade de Medicina, Maastricht University, MIMETAS BV, Medical Education Research And Innovation Center S.R.L., Leiden University, Mercodia Aktiebolag, University Hospital, Saarland, Amsterdam University Medical Center, UMC Utrecht, Nordic Bioscience A/S, University Hospital, Antwerp, Roche Pharma AG, Novo Nordisk A/S, Harokopio University, Inventiva Pharma, Franciscus Gasthuis & Vlietland (Hospital), Andaluz Health Service
Leads: Julius Clinical

This content was sourced from clinicaltrials.gov