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Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01828528
First received: April 3, 2013
Last updated: November 23, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Procedure: Sleeve gastrectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • 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.


Biospecimen Retention:   Samples With DNA
Whole blood, Liver tissue

Enrollment: 26
Study Start Date: April 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NAFLD after SG
26 patients with NAFLD undergoing sleeve gastrectomy (SG).
Procedure: Sleeve gastrectomy
An intra-operative liver biopsy was performed in 20 patients

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828528

Locations
Israel
Liver Disease Center, Sheba Medical Center, Tel-Hashomer
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ziv Ben-Ari, Prof Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01828528     History of Changes
Other Study ID Numbers: SHEBA-12-0026-ZB-CTIL
Study First Received: April 3, 2013
Last Updated: November 23, 2016

Keywords provided by Sheba Medical Center:
Nonalcoholic fatty liver disease
Nonalcoholic steatohepatitis
Obesity
Bariatric surgery
Weight loss

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases

ClinicalTrials.gov processed this record on May 25, 2017