NAFLDNCT02122263
Transient Elastography of the Liver ( Fibroscan ) and Bariatric Surgery
An observational study of NAFLD, run by Ziv Hospital at 1 site in Israel.
Trial summary
To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Apr 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 obese NAFLD patients after sleeve gastrectomy surgery
Who may be able to join
- Subjects 18-65 years old
- BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities
- Willingness to take a metformin once a day for 6 months
- Ultrasound diagnosed NAFLD patients
- Reading and speaking Hebrew
Who cannot join
- Subject with mental illness or cognitive deterioration
- Use of probiotic/antibiotic 3 mounts before surgery
- Use of other antibiotic for more than 1 week during the study
- Drug addiction
- Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
- Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens)
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- Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study
- Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease)
- Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose
- Subjects who began a new lipid reduction medications less than 6 months prior to the initiation of the study
- Subjects with chronic conditions that could interfere with our study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions
- Bariatric surgery in the past
Trial locations and contacts
1 site in 1 country.
Israel1 site
ZIv Medical Center
Safed, Israel, 13100
Nimer Assy, MD, 97246828442, assy.n@ziv.health.gov.il
About this study
To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.
Read the detailed description
The effect of bariatric surgery on the extent of fat and extent of liver fibrosis following sleeve gastrtrectomy is unknown. Methods : 60 obese NAFLD patients will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, and at 6 Month and will include: abdominal US, Fibroscan elastography , biochemical tests, anthropometric measurements, and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. Primary Outcome Measures: Liver fat quantification (controlled attenuation parameter;CAP ) and stiffness at baseline and at 6 months by fibroscan. The liver stiffness is measured by Fibroscan in a volume of approximates 1 cm wide and 4 cm long cylinder, representing 1/500 of liver tissue (100 times greater than a biopsy sample). The results of the Fibroscan will be expressed in KiloPascals (kPa). The Fibroscan XL probe reduces Fibroscan failure and facilitates reliable liver stiffness measurement in obese patients compared with the common M probe. Secondary Outcome Measures: metabolic parameters including insuline resistance, CRP, MDA, Paraoxonase, and bile acid levels. Quality of life and Food tolerance after bariatric surgery
- Conditions
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NAFLD after sleeve gastrectomy surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transient elastography
Measured: 6 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assy Nimer, Ziv Hospital
- Investigators
- Nimer Assy, Prof, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122263
- Sponsor's protocol ID
- 0007-14-ZIV
- Status last verified
- Apr 2014
- First submitted
- 20 Mar 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Elastography of the Liver ( Fibroscan ) and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02122263
- Acronym / sponsor ID
- 0007-14-ZIV
- Conditions
- NAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 24 Apr 2014 (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.
To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.
Detailed description
The effect of bariatric surgery on the extent of fat and extent of liver fibrosis following sleeve gastrtrectomy is unknown. Methods : 60 obese NAFLD patients will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, and at 6 Month and will include: abdominal US, Fibroscan elastography , biochemical tests, anthropometric measurements, and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. Primary Outcome Measures: Liver fat quantification (controlled attenuation parameter;CAP ) and stiffness at baseline and at 6 months by fibroscan. The liver stiffness is measured by Fibroscan in a volume of approximates 1 cm wide and 4 cm long cylinder, representing 1/500 of liver tissue (100 times greater than a biopsy sample). The results of the Fibroscan will be expressed in KiloPascals (kPa). The Fibroscan XL probe reduces Fibroscan failure and facilitates reliable liver stiffness measurement in obese patients compared with the common M probe. Secondary Outcome Measures: metabolic parameters including insuline resistance, CRP, MDA, Paraoxonase, and bile acid levels. Quality of life and Food tolerance after bariatric surgery
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAFLD after sleeve gastrectomy surgery | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 obese NAFLD patients after sleeve gastrectomy surgery
Key inclusion criteria (5 listed)
- Subjects 18-65 years old
- BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities
- Willingness to take a metformin once a day for 6 months
- Ultrasound diagnosed NAFLD patients
- Reading and speaking Hebrew
Key exclusion criteria (12 listed)
- Subject with mental illness or cognitive deterioration
- Use of probiotic/antibiotic 3 mounts before surgery
- Use of other antibiotic for more than 1 week during the study
- Drug addiction
- Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transient elastography
Time frame: 6 month after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
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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.
Nimer Assy, Prof principal investigator
Ziv Medical Center
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 NAFLD, run by Ziv Hospital 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Apr 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimer Assy, MD (972-4-6828442, assy.n@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transient elastography (time frame: 6 month after baseline). 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 24 Apr 2014.