Trial record 9 of 154 for:    Open Studies | "Fatty Liver"

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

This study is not yet open for participant recruitment.
Verified November 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Prof. Ziv Ben-Ari MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01987310
First received: October 27, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention
Non Alcoholic Fatty Liver Disease
Drug: atorvastatin
Behavioral: lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Change from baseline in liver steatosis at 6 months [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 6 months and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at diagnosis and after 6 months and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at diagnosis 6 months and 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: December 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Statin
statin therapy (atorvastatin 20 mg/d) for 6 months
Drug: atorvastatin
atorvastatin 20 mg per day for 6 months
Other Name: 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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01987310

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 5265601
Contact: Ziv Ben-Ari, MD    972-3-5307180      
Contact: Oranit Cohen-Ezra, MD    972-3-5307181      
Principal Investigator: Ziv Ben-Ari, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ziv Ben-Ari, MD Sheba Medical Center, Ramat Gan, Israel
  More Information

No publications provided

Responsible Party: Prof. Ziv Ben-Ari MD, Head of Disease Medical Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01987310     History of Changes
Other Study ID Numbers: SHEBA-13-0694-ZBE-CTIL
Study First Received: October 27, 2013
Last Updated: November 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
non alcoholic fatty liver disease
endothelial function
liver steatosis
liver fibrosis
statin treatment

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014