NCT05651724 Global Research Initiative for Patients Screening on MASH
| NCT ID | NCT05651724 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Julius Clinical |
| Condition | MASH |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2031-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2023-06-30 with a primary completion date of 2031-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 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.
Contact & Investigator
Manuel Castro Cabezas, MD/PhD
PRINCIPAL INVESTIGATOR
Sint Franciscus Gasthuis
Frequently Asked Questions
Who can join the NCT05651724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying MASH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05651724 currently recruiting?
Yes, NCT05651724 is actively recruiting participants. Contact the research team at griponmash@juliusclinical.com for enrollment information.
Where is the NCT05651724 trial being conducted?
This trial is being conducted at Brussels, Belgium, Antwerp, Belgium, Prague, Czechia, Paris, France and 9 additional locations.
Who is sponsoring the NCT05651724 clinical trial?
NCT05651724 is sponsored by Julius Clinical. The principal investigator is Manuel Castro Cabezas, MD/PhD at Sint Franciscus Gasthuis. The trial plans to enroll 10,000 participants.