Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

Completed

• Conditions: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease
• Interventions: Procedure: Sleeve gastrectomy

• Registration Number: NCT01828528
• Lead Sponsor: Sheba Medical Center

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-03
• Study First Submitted QC: 2013-04-07
• Study First Posted: 2013-04-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD after SG	Sleeve gastrectomy	26 patients with NAFLD undergoing sleeve gastrectomy (SG).

Primary Outcome Measures

Name	Time	Method
Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.	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

Name	Time	Method
Change in cholecystokinin levels before and after the surgery.	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.
Change of postoperative cardiovascular risk compared to baseline.	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).

Trial Locations

Locations (1)

Liver Disease Center, Sheba Medical Center, Tel-Hashomer; 🇮🇱 Ramat-Gan, Israel