NCT03391401

Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 204 (actual)
• Sponsor: St. Franziskus Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of NAFLD after weight loss. As other factors such as the microbiome or muscle and fatty tissue also influence the development of obesity and liver diseases, it is planned to examine these parameters before and after bariatric surgery as well. Tissue biopsies will therefore be taken during the surgery, and blood as well as stool samples will be collected and compared for suitable biomarkers before and after the intervention.

Conditions

• Obesity, Morbid
• Bariatric Surgery Candidate
• NAFLD
• Microbiome

Interventions

Type	Name	Description
PROCEDURE	Bariatric surgery	Any bariatric operation that is considered as a standard procedure in bariatric surgery (i.e. sleeve gastrectomy, roux-en-y gastric bypass, mini-gastric / one anastomosis gastric bypass, redo and revisional bariatric surgery).

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-01-31
• Completion: 2021-07-31
• First posted: 2018-01-05
• Last updated: 2021-10-07

Locations

2 sites across 1 country: Germany