Global Research Initiative for Patients Screening on MASH

Launched by JULIUS CLINICAL · Dec 13, 2022

Keywords

ClinConnect Summary

The GRIPonMASH clinical trial is focused on improving how doctors identify and care for patients with a serious liver condition known as metabolic dysfunction-associated steatohepatitis (MASH) and its earlier form, metabolic dysfunction-associated steatotic liver disease (MASLD). This study is being conducted in 10 European countries and aims to help primary care providers use the latest guidelines to screen for these liver issues, especially among people who may also have conditions like type 2 diabetes, obesity, or high blood pressure.

To be eligible for the trial, participants should be adults aged 18 or older who have recently been diagnosed with type 2 diabetes, metabolic syndrome, obesity, or high blood pressure. This means that if you have certain health measurements—like a high blood sugar level or a specific body weight—you could qualify. If you join the study, you will receive care and information to help monitor and manage your liver health, while also contributing to research that could improve treatment for others in the future. However, there are some exclusions, such as having certain liver diseases or being pregnant, to ensure everyone's safety during the trial.

Gender

ALL

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.