Additive effect of Roux-en Y Gastric Bypass to preoperative Very low calorie diet on non-alcoholic fatty liver diseases (NAFLD, NASH)-A randomized controlled trial

Not Applicable

Recruiting

• Conditions: K75.8; E66.0; Other specified inflammatory liver diseases; Obesity due to excess calories

• Registration Number: DRKS00027810
• Lead Sponsor: Chirurgische Klinik Universitätsmedizin Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-03
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in NASH activity score (NAS)

Secondary Outcome Measures

Name	Time	Method
- laboratory parameters (small blood count, AP, gamma-GT, Bilirubin, ALT, AST, Albumin, PT, Choline esterase, blood sugar, HbA1c)<br>- change in NAS components<br> ~ steatosis<br> ~ lobular inflammation<br> ~ hepatocyte ballooning<br>- change in fibrosis<br>- change in estimated percentage of liver fat <br>- Body weight<br>- NAFLD Fibrosis score<br>- Change in Fibrosis (Kleiner Scale)<br>