Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease
|ClinicalTrials.gov Identifier: NCT01828528|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment|
|Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis||Procedure: Sleeve gastrectomy|
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
U.S. FDA Resources
NAFLD after SG
26 patients with NAFLD undergoing sleeve gastrectomy (SG).
Procedure: Sleeve gastrectomy
An intra-operative liver biopsy was performed in 20 patients
- 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:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828528
|Liver Disease Center, Sheba Medical Center, Tel-Hashomer|
|Ramat-Gan, Israel, 52621|
|Principal Investigator:||Ziv Ben-Ari, Prof||Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel|