Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease
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|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|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|