K75.8 E66.0
Conditions
Interventions
Group 1: This Arm will receive two liver biopsies. The patients will receive RYGB on grounds of morbid obesity as recommended via guidelines. Prior to surgery and two weeks after surgery, the patient
Sponsors
Chirurgische Klinik Universitätsmedizin Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Patients scheduled for RYGB - BMI >35 kg/m2 - Age equal or greater than 18 years - Age equal or lower than 65 years - NAFLD-fibrosis-Score equal or greater than -1.455 - Informed consent
Exclusion criteria
Exclusion criteria: - Secondary causes of steatosis - Daily alcohol consumption of more than 10g in female / 20g in male - Binge drinking of alkohol - Impaired mental state or language problems - Pregnancy - Expected lack of compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in NASH activity score (NAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - laboratory parameters (small blood count, AP, gamma-GT, Bilirubin, ALT, AST, Albumin, PT, Choline esterase, blood sugar, HbA1c) - change in NAS components ~ steatosis ~ lobular inflammation ~ hepatocyte ballooning - change in fibrosis - change in estimated percentage of liver fat - Body weight - NAFLD Fibrosis score - Change in Fibrosis (Kleiner Scale) | — |
Countries
Germany
Contacts
Public ContactAlida Finze
Chirurgische Klinik, Universitätsmedizin Mannheim
Outcome results
None listed