Nonalcoholic Fatty Liver DiseaseNCT01828528
Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- What is being tested?
- Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Aug 2016
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 26 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing sleeve gastrectomy (SG) at Surgery C department at Sheba Medical Center, Israel.
Who may be able to join
- 20≤ age ≤80
- BMI>35kg/m2
- Men and women
- Fatty infiltration in liver ultrasonography
Who cannot join
- Alcohol drinking > 140g/week
- Presence of hepatitis B or C or HIV
- Known liver disease such as:
- Wilson's disease
- hemochromatosis
- α1-antitrypsin deficiency
Show all 9Show fewer
- autoimmune liver disease
- primary biliary cirrhosis
- primary sclerosing cholangitis)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Liver Disease Center, Sheba Medical Center, Tel-Hashomer
Ramat Gan, 52621
About this study
Official title: The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures
The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.
- Being tested
- Sleeve gastrectomy
- Keywords
- Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Obesity, Bariatric surgery, Weight loss
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
An intra-operative liver biopsy was performed in 20 patients
| Study group | Role | What they receive |
|---|---|---|
| NAFLD after SG | 26 patients with NAFLD undergoing sleeve gastrectomy (SG). Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.
Measurements to be performed to assess liver disease stage at baseline and at 8-12 days and 12, 24 and 48 weeks after surgery:
- Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, prothrombin-time (PT), international normalized ratio (INR), Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (insulin, glucose, HbA1c).
- Blood tests of adiponectin (only at baseline and 48 weeks after surgery).
- Fibroscan test for quantifying liver fibrosis by means of elastography (only at baseline and 48 weeks after surgery).
- A blood test (FibroMax) for determining the stage and grade of liver damage (only at baseline and at 24 and 48 weeks after surgery).
- OWLiver® test (a serum based test that can discriminate NAFLD from steatohepatitis using metabolomics) at baseline and 48 weeks after surgery.
Measured: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.
Secondary outcomes (2)
Change of postoperative cardiovascular risk compared to baseline.
Patients will undergo brachial artery flow-mediated dilation (FMD) test (surrogate marker for endothelial function and cardiovascular risk).
Measured: Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.
Change in cholecystokinin levels before and after the surgery.
In addition, gastric cholecystokinin levels will be measured from the removed stomach tissue.
Measured: Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ziv Ben-Ari, Prof, Principal investigator, Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828528
- Sponsor's protocol ID
- SHEBA-12-0026-ZB-CTIL
- Status last verified
- Nov 2016
- First submitted
- 3 Apr 2013
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures
- ClinicalTrials.gov ID
- NCT01828528
- Acronym / sponsor ID
- SHEBA-12-0026-ZB-CTIL
- Keywords
- Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Obesity, Bariatric surgery, Weight loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Apr 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 purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAFLD after SG | – | Procedure: Sleeve gastrectomy26 patients with NAFLD undergoing sleeve gastrectomy (SG). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 26 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing sleeve gastrectomy (SG) at Surgery C department at Sheba Medical Center, Israel.
Key inclusion criteria (4 listed)
- 20≤ age ≤80
- BMI>35kg/m2
- Men and women
- Fatty infiltration in liver ultrasonography
Key exclusion criteria (9 listed)
- Alcohol drinking > 140g/week
- Presence of hepatitis B or C or HIV
- Known liver disease such as:
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 |
|---|---|---|
| Sleeve gastrectomyAn intra-operative liver biopsy was performed in 20 patients | Procedure or surgery | NAFLD after SG |
Primary outcome
Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.
Time frame: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.
Measurements to be performed to assess liver disease stage at baseline and at 8-12 days and 12, 24 and 48 weeks after surgery: 1. Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, prothrombin-time (PT), international normalized ratio (INR), Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (insulin, glucose, HbA1c). 2. Blood tests of adiponectin (only at baseline and 48 weeks after surgery). 3. Fibroscan test for quantifying liver fibrosis by means of elastography (only at baseline and 48 weeks after surgery). 4. A blood test (FibroMax) for determining the stage and grade of liver damage (only at baseline and at 24 and 48 weeks after surgery). 5. OWLiver® test (a serum based test that can discriminate NAFLD from steatohepatitis using metabolomics) at baseline and 48 weeks after surgery.
2 secondary outcomes
Change of postoperative cardiovascular risk compared to baseline.
Time frame: Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.
Change in cholecystokinin levels before and after the surgery.
Time frame: Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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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, Prof principal investigator
Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 28 Nov 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below. (time frame: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.). 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 28 Nov 2016.