NCT01987310

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Non Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	atorvastatin	atorvastatin 20 mg per day for 6 months
BEHAVIORAL	lifestyle counseling	lifestyle modification by dietician counseling and follow up

Timeline

• Start date: 2015-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-11-19
• Last updated: 2017-04-27

Locations

1 site across 1 country: Israel