Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Conditions
Keywords
Nonalcoholic fatty liver disease, Nonalcoholic steatohepatitis, Obesity, Bariatric surgery, Weight loss
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.
Interventions
PROCEDURESleeve gastrectomy
An intra-operative liver biopsy was performed in 20 patients
Sponsors
Sheba Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
Israel
Outcome results
None listed