Global Research Initiative for Patients Screening on NASH

GRIP on NASH will assist primary care physicians and 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 fatty liver disease and to raise awareness on fatty liver disease. The primary objective is to implement a transmural patient care pathway, in order to identify patients with non-alcoholic fatty liver diseases (NAFLD) and its progressive form non-alcoholic steatohepatitis (NASH) in primary care centres and clinics in 10 European countries.

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 mellitusAt least 2 times a fasting glucose > 7,0 mmol/LOr elevated non-fasting glucose >11,1 mmol/L 2 hrs after OGTTObesityBody mass index (BMI) > 30Or waist circumferences (Europids): male ≥ 94 cm, female ≥ 80 cmArterial hypertension - Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHgMetabolic syndrome- Central obesity defined as waist circumference (Europids): male ≥ 94 cm and female ≥ 80 cm (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 abnormalityReduced 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 abnormalityRaised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertensionRaised 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, etc);The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;(Excessive) alcohol use: > 3 units/day in males and > 2 units/day in females;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.