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

St. Franziskus Hospital

Status: Completed

Conditions: Bariatric Surgery Candidate; Microbiome; NAFLD; Obesity, Morbid

Treatments: Procedure: Bariatric surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03391401

2017110

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI above 40 kg/sqm or
• BMI above 35 kg/sqm and comorbidities related to morbid obesity (e.g. type 2 diabetes, hypertension, coronary heart disease, dyslipoproteinemia, sleep apnea, and others

Exclusion criteria

• BMI below 35 kg/sqm
• no informed consent
• patient not suitable for bariatric surgery (severe psychological disorder, pregnancy, drug abuse, active malignant or other consuming disease

Trial design

204 participants in 1 patient group

Adip1

Description:

Patients with morbid obesity (i.e. BMI \>35 kg/sqm) and age \>18 scheduled for bariatric surgery (all standard procedures included)

Treatment:

Procedure: Bariatric surgery