Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828528
• Other study ID #: SHEBA-12-0026-ZB-CTIL
• Status: Completed
• Phase: N/A
• First received: April 3, 2013
• Last updated: November 23, 2016
• Start date: April 2013
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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. a1-antitrypsin deficiency

4. autoimmune liver disease

5. primary biliary cirrhosis

6. primary sclerosing cholangitis)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Procedure:
• Sleeve gastrectomy
An intra-operative liver biopsy was performed in 20 patients

Locations

Country	Name	City	State
Israel	Liver Disease Center, Sheba Medical Center, Tel-Hashomer	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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).	Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.	No
Secondary	Change in cholecystokinin levels before and after the 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.	No