non-alcoholic steatohepatitis / fatty liver disease
Conditions
Interventions
None listed
Sponsors
Franciscus Gasthuis & Vlietland
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Participants must fulfil the criteria of the International Federation for the Surgery of Obesity (IFSO) at screening. 2. Participants must be able to understand the nature of the study and written informed consent must be obtained before any study specific interventions are performed.
Exclusion criteria
Exclusion criteria: 1. Participants with an established diagnosis of liver pathology like, but not limited to: a. Hepatitis B b. Hepatitis C c. Autoimmune hepatitis d. Wilson*s disease e. Hemochromatosis f. Primary biliary cholangitis g. Primary sclerosing cholangitis h. Alcoholic liver disease 2. Histologically documented liver cirrhosis (fibrosis stage F4), at screening or in a historical biopsy. 3. Participants with active HIV infection and/or treatment. 4. Participants with diagnosed malignancies with or without active treatment. 5. Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient*s safety or ability to complete the study. 6. The participant does not understand Dutch. 7. The participant is younger than 18 years or older than 65 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steatosis (CAP) and liver elasticity (E) will be analyzed comparing the before and one year after bariatric surgery measurements using a paired t-test (if normally distributed otherwise the Wilcoxon signed rank test). We aim to compare the classification of the liver fibrosis (F1-4) according to the TE measurement with the biopsy*s. Therefore, we will use a Chi-square test for trend to determine if there is any significant difference of classification between the two methods. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. We will compare elasticity and steatosis at one year after bariatic surgery between the following surgery groups: gastric sleeve resection, gastric minibypass and Roux-en-Y gastric bypass 2. Per genetic marker we will determine if change in steatosis and elasticity differs for presence/absence of the marker one year after surgery. 3. Association between the presence NAFLD/NASH and the cIMT and PWV measurement and cardiac dysfunction will be analyzed. 4. We will analyze if there is a correlation between the NAFLD/NASH fibrosis stadia (F1-F4) and the cIMT and PWV measurement. We will do the same for the cardiac dysfunction. 5. The association between the changes of liver fibrosis with the presence of cardiac dysfunction 1 year after bariatric surgery will be analyzed. 6. The proportion of patients with obesity with high E measurements (>= F2) and patients with obesity with low E measurements ( | — |
Countries
Netherlands
Outcome results
None listed