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

April 25, 2017 updated by: Prof. Ziv Ben-Ari MD, Sheba Medical Center
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.

Study Overview

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Statin
statin therapy (atorvastatin 20 mg/d) for 6 months
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
lifestyle modification by dietician counseling and follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in liver steatosis at 6 months
Time Frame: 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.
baseline, 6 months and 12 months
change from baseline in liver fibrosis at 6 months
Time Frame: 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.
baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients
Time Frame: 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
12 months
relationship between blood parameters and liver steatosis and fibrosis
Time Frame: 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
12 months
relationship between blood parameters and endothelial function
Time Frame: 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
at diagnosis and after 6 months and 12 months
change from baseline in endothelial function at 6 months
Time Frame: 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.
at diagnosis 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ziv Ben-Ari, MD, Sheba Medical Center, Ramat Gan, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

October 27, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (ESTIMATE)

November 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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