Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

November 23, 2016 updated by: Sheba Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

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

  • Israel
      • Ramat-Gan, Israel, 52621
        • Liver Disease Center, Sheba Medical Center, Tel-Hashomer

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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

26 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing sleeve gastrectomy (SG) at Surgery C department at Sheba Medical Center, Israel.

Description

Inclusion Criteria:

  • 20≤ age ≤80
  • BMI>35kg/m2
  • Men and women
  • Fatty infiltration in liver ultrasonography

Exclusion Criteria:

  • Alcohol drinking > 140g/week
  • Presence of hepatitis B or C or HIV

  • Known liver disease such as:

    1. Wilson's disease
    2. hemochromatosis
    3. α1-antitrypsin deficiency
    4. autoimmune liver disease
    5. primary biliary cirrhosis
    6. primary sclerosing cholangitis)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD after SG
26 patients with NAFLD undergoing sleeve gastrectomy (SG).
Procedure: Sleeve gastrectomy
An intra-operative liver biopsy was performed in 20 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Patients will undergo brachial artery flow-mediated dilation (FMD) test (surrogate marker for endothelial function and cardiovascular risk).
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.
In addition, gastric cholecystokinin levels will be measured from the removed stomach tissue.
Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Ziv Ben-Ari, Prof, Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, 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

April 1, 2013

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 7, 2013

First Posted (ESTIMATE)

April 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-0026-ZB-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.

Clinical Trials on Nonalcoholic Fatty Liver Disease

Clinical Trials on Sleeve gastrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe