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

Sponsor

Sheba Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01987310

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Drug: atorvastatin Behavioral: lifestyle counseling	N/A

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:

complete physical examination
blood pressure measurement
assessment of height and weight, body mass index and waist circumference
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
Liver elastography and sonographic liver fat quantification
Brachial artery flow-mediated dilatation (FMD) measurement

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Statin statin therapy (atorvastatin 20 mg/d) for 6 months	Drug: atorvastatin atorvastatin 20 mg per day for 6 months Other Names: Atorvastatin Teva, Lipitor, Litorva
No Intervention: usual care follow up group with no intervention
Active Comparator: lifestyle counseling lifestyle modification by dietician counseling and follow-up	Behavioral: lifestyle counseling lifestyle modification by dietician counseling and follow up

Arm

Intervention/Treatment

Active Comparator: Statin

statin therapy (atorvastatin 20 mg/d) for 6 months

Drug: atorvastatin

atorvastatin 20 mg per day for 6 months

Other Names:

Atorvastatin Teva, Lipitor, Litorva

No Intervention: usual care

follow up group with no intervention

Active Comparator: lifestyle counseling

lifestyle modification by dietician counseling and follow-up

Behavioral: lifestyle counseling

lifestyle modification by dietician counseling and follow up

Outcome Measures

Primary Outcome Measures

Change from baseline in liver steatosis at 6 months [baseline, 6 months and 12 months]
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver steatosis and fibrosis. Liver steatosis will be assessed by sonographic liver fat quantification (hepatorenal sonographic index.
change from baseline in liver fibrosis at 6 months [baseline, 6 months and 12 months]
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on liver fibrosis. Liver fibrosis will be assessed by Real-Time shear wave elastography.

Secondary Outcome Measures

endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients [12 months]
measurement of endothelial function in NAFLD patients and finding the correlation between the degree of endothelial dysfunction and the severity of fatty liver disease. Endothelial function will be assessed by brachial artery flow-mediated (FMD) measurement at diagnosis and after 6 and 12 months. The severity of fatty liver disease will be assessed by liver elastography and sonographic liver fat quantification
relationship between blood parameters and liver steatosis and fibrosis [12 months]
levels of liver enzymes, liver synthetic function, blood lipids, insulin resistance, ferritin, adiponectin, C reactive protein, Tumor necrosis factor alpha and ceruloplasmin and their correlation with liver steatosis and fibrosis
relationship between blood parameters and endothelial function [at diagnosis and after 6 months and 12 months]
levels of liver enzymes, liver synthetic function, blood lipids, insulin resistance, ferritin, adiponectin, C reactive protein, tumor necrosis factor alpha and ceruloplasmin and their correlation with endothelial function
change from baseline in endothelial function at 6 months [at diagnosis 6 months and 12 months]
Impact of statin treatment(which will be given for 6 months) compared to no intervention or lifestyle modification on endothelial function. Endothelial function will be assessed by flow mediated dilatation (FMD) of brachial artery.