Non Alcoholic Fatty Liver DiseaseNCT01987310
Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
A study testing atorvastatin and lifestyle counseling in people with Non Alcoholic Fatty Liver Disease, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- atorvastatin and lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects willing to comply with study requirements and have signed an informed consent form
- fatty liver per abdominal ultrasound or liver biopsy
Who cannot join
- 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
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- subjects with known dyslipidemia requiring drug treatment
- subjects with diabetes mellitus
- history of drug or alcohol abuse
- refusal to sig the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- atorvastatin, lifestyle counseling
- Keywords
- non alcoholic fatty liver disease, endothelial function, liver steatosis, liver fibrosis, statin treatment
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called Atorvastatin Teva, Lipitor, Litorva
atorvastatin 20 mg per day for 6 months
lifestyle counselingBehavioural
lifestyle modification by dietician counseling and follow up
| Study group | Role | What they receive |
|---|---|---|
| Statin | Active comparator | statin therapy (atorvastatin 20 mg/d) for 6 months Receives: Drug: atorvastatin |
| usual care | No intervention | follow up group with no intervention |
| lifestyle counseling | Active comparator | lifestyle modification by dietician counseling and follow-up Receives: Behavioral: lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in liver steatosis at 6 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.
Measured: baseline, 6 months and 12 months
change from baseline in liver fibrosis at 6 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.
Measured: baseline, 6 months and 12 months
Secondary outcomes (4)
endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients
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
Measured: 12 months
relationship between blood parameters and liver steatosis and fibrosis
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
Measured: 12 months
relationship between blood parameters and endothelial function
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
Measured: at diagnosis and after 6 months and 12 months
change from baseline in endothelial function at 6 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.
Measured: at diagnosis 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: the study was stopped because of lack of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ziv Ben-Ari MD, Sheba Medical Center
- Investigators
- Ziv Ben-Ari, MD, Principal investigator, Sheba Medical Center, Ramat Gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987310
- Sponsor's protocol ID
- SHEBA-13-0694-ZBE-CTIL
- Status last verified
- Apr 2017
- First submitted
- 27 Oct 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Endothelial Function in Patients With Non Alcoholic Fatty Liver Disease and the Impact of Statin Treatment
- ClinicalTrials.gov ID
- NCT01987310
- Acronym / sponsor ID
- SHEBA-13-0694-ZBE-CTIL
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- non alcoholic fatty liver disease, endothelial function, liver steatosis, liver fibrosis, statin treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the study was stopped because of lack of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Statin | Active comparator | Drug: atorvastatinstatin therapy (atorvastatin 20 mg/d) for 6 months |
| usual care | No intervention | –follow up group with no intervention |
| lifestyle counseling | Active comparator | Behavioral: lifestyle counselinglifestyle modification by dietician counseling and follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects willing to comply with study requirements and have signed an informed consent form
- fatty liver per abdominal ultrasound or liver biopsy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatinAlso: Atorvastatin Teva, Lipitor, Litorvaatorvastatin 20 mg per day for 6 months | Drug | Statin |
| lifestyle counselinglifestyle modification by dietician counseling and follow up | Behavioural | lifestyle counseling |
Primary outcome
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.
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.
4 secondary outcomes
endothelial function in Non-Alcoholic Fatty Liver Disease (NAFLD) patients
Time frame: 12 months
relationship between blood parameters and liver steatosis and fibrosis
Time frame: 12 months
relationship between blood parameters and endothelial function
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziv Ben-Ari, MD principal investigator
Sheba Medical Center, Ramat Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin and lifestyle counseling in people with Non Alcoholic Fatty Liver Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in liver steatosis at 6 months (time frame: baseline, 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.