Metabolic dysfunction Associated Fatty Liver Disease Non-Alcoholic Steatohepatitis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria study groups: • >= 18 years of age • Signed informed consent • Some degree of liver steatosis and fibrosis (FibroScan F1-F4) with or without diagnosis of diabetes mellitus Inclusion criteria control group: • >= 18 years of age • Signed informed consent
Exclusion criteria
Exclusion criteria: • Underlying liver disease with other aetiology than Metabolic dysfunction Associated Fatty Liver Disease • Use of anti-platelet (salicylates, P2Y12 inhibitors, dipyridamole) or anti-hemostatic (heparins, vitamin K antagonists, direct oral anticoagulants) drugs • Use of Non-Steroid Anti-Inflammatory Drugs 4 days prior to inclusion • Documented history of hereditary thrombophilia or haemophilia • Current malignancy • Pregnancy • Pre-existing immunosuppressive status (HIV positivity, previous solid organ transplant) • Transfusion of blood products 7 days prior to inclusion • Not willing to be notified of FibroScan results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in platelet function after in vitro administration of active metabolites of antiplatelet drugs (aspirin, clopidogrel, ticagrelor) to the blood of patients with various stages of fibrosis due to MAFLD, compared to healthy controls. To estimate platelet function, we will assess platelet adhesion by Flow Based Adhesion, platelet activation by Flow Cytometry, and platelet aggregation by Whole Blood Aggregation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline values, such as body weight, height, medical history, use of medications, smoking will be assessed. Parameters to define stage of (fibrosis due to) MAFLD consist of FibroScan Controlled Attenuation Parameter Scores (dB/m) and FibroScan Fibrosis Score (kPa). Other parameters involved in assessing the hemostatic status consist of markers for activation of platelets and coagulation (platelet factor 4, prothrombin fragment 1+2, thrombin-antithrombin complex), routine blood tests (platelet count, hemoglobin, von Willebrand factor, fibrinogen, prothrombin time, international normalized ratio, activated partial thromboplastin time). | — |
Countries
Netherlands
Outcome results
None listed