Global Research Initiative for Patients Screening on MASH
NCT ID: NCT05651724
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2023-06-30
2031-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Echosens
INDUSTRY
MIMETAS BV
UNKNOWN
Nordic Bioscience A/S
INDUSTRY
Elevate BV
UNKNOWN
Leiden University
OTHER
Amsterdam University Medical Center
OTHER
Andaluz Health Service
OTHER_GOV
National Research Council, Institute of Clinical Physiology, Italy
OTHER
Leiden University Medical Center
OTHER
Université Libre de Bruxelles
OTHER
University Hospital, Antwerp
OTHER
Catholic University of the Sacred Heart
OTHER
Medical Education Research And Innovation Center S.R.L.
UNKNOWN
EUROPEAN LIVER PATIENTS ASSOCIATION
UNKNOWN
Harokopio University
OTHER
General University Hospital, Prague
OTHER
Novo Nordisk A/S
INDUSTRY
Maastricht University
OTHER
Mercodia Aktiebolag
UNKNOWN
EXIT071 BV
UNKNOWN
European Atherosclerosis Society
OTHER
MetaDeq Limited
UNKNOWN
Associação para Investigação e Desenvolvimento da Faculdade de Medicina
UNKNOWN
Institute of Cardiometabolism and Nutrition, France
OTHER
University Hospital, Saarland
OTHER
Roche Pharma AG
INDUSTRY
Inventiva Pharma
INDUSTRY
Biocellvia
UNKNOWN
Franciscus Gasthuis & Vlietland (Hospital)
OTHER
Julius Clinical
INDUSTRY
Responsible Party
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Principal Investigators
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Manuel Castro Cabezas, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Sint Franciscus Gasthuis
Diederick E. Grobbee, MD/PhD/FESC
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Oscar H. Franco, MD/PhD/FESC/FFPH
Role: STUDY_CHAIR
UMC Utrecht
Locations
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Hôpital Erasme, Cliniques Universitaires De Bruxelles
Brussels, Vlaams-brabant, Belgium
Antwerp University Hospital
Antwerp, , Belgium
4th internal clinic General University Hospital
Prague, Bohemia, Czechia
Hôpital de la Pitié Salpêtrière
Paris, Il-de-France, France
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany
Harokopio University of Athens
Athens, , Greece
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)
Rome, Lazio, Italy
Amsterdam UMC
Amsterdam, South Holland, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands
ULSSM - Unidade Local de Saúde Santa Maria, E.P.E
Lisbon, , Portugal
Sacele Municipal Hospital
Săcele, Brașov County, Romania
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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Central Contacts
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References
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de Jong VD, Alings M, Bruha R, Cortez-Pinto H, Dedoussis GV, Doukas M, Francque S, Fournier-Poizat C, Gastaldelli A, Hankemeier T, Holleboom AG, Miele L, Moreno C, Muris JWM, Ratziu V, Romero-Gomez M, Schattenberg JM, Serfaty L, Stefan DC, Tushuizen ME, Verheij J, Willemse J, Franco OH, Grobbee DE, Castro Cabezas M; GRIPonMASH consortium. Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study. BMJ Open. 2025 May 30;15(5):e092731. doi: 10.1136/bmjopen-2024-092731.
Related Links
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GRIPonMASH consortium website
Other Identifiers
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GOM
Identifier Type: -
Identifier Source: org_study_id
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