- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987310
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
Status
Withdrawn
Conditions
Intervention / Treatment
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 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
-
-
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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:
|
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
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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
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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
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at diagnosis and after 6 months and 12 months
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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.
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at diagnosis 6 months and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-13-0694-ZBE-CTIL
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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