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

Not Applicable

Withdrawn

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Behavioral: lifestyle counseling; Drug: atorvastatin

• Registration Number: NCT01987310
• Lead Sponsor: Sheba Medical Center

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.

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

Study Timeline

• Study First Submitted: 2013-10-27
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Start: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifestyle counseling	lifestyle counseling	lifestyle modification by dietician counseling and follow-up
Statin	atorvastatin	statin therapy (atorvastatin 20 mg/d) for 6 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel