Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment

Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment

The aim of the current study is to evaluate the association of fatty liver severity and endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients and to find the impact of statin treatment compared to usual care or life style modification on endothelial function, liver steatosis and fibrosis.

The study cohort will include 150 patients with fatty liver per ultrasound or histology. The patients will be divided randomly to one of three arms: follow up group, lifestyle modification group, and statins therapy (Atorvastatin 20mg/d for 6 months). at screening, after 6 months (end of treatment), and 12 months the patients will undergo:

1. complete physical examination
2. blood pressure measurement
3. assessment of height and weight, body mass index and waist circumference
4. blood samples for complete blood count, fasting plasma glucose, fasting plasma insulin, lipid profile, liver enzymes, albumin, bilirubin, Prothrombin time (PT INR), Hemoglobin A1c, ferritin, adiponectin, C-reactive protein, Tumor necrosis factor alpha, Lipoprotein-phospholipase A2, Apolipoproteins B100, A1, C3, C4, ceruloplasmin
5. Liver elastography and sonographic liver fat quantification
6. Brachial artery flow-mediated dilatation (FMD) measurement

Inclusion Criteria:

• subjects willing to comply with study requirements and have signed an informed consent form
• fatty liver per abdominal ultrasound or liver biopsy

Exclusion Criteria:

• alcohol drinking >140g/week
• presence of hepatitis B or C or HIV
• known liver disease other than fatty liver
• usage of drugs known to cause liver steatosis
• subjects with known allergies or hypersensitivity to statins
• subjects with known cardiovascular/cerebrovascular disease
• subjects with known dyslipidemia requiring drug treatment
• subjects with diabetes mellitus
• history of drug or alcohol abuse
• refusal to sig the informed consent form