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

Completed

• Conditions: Microbiome; Obesity, Morbid; Bariatric Surgery Candidate; NAFLD
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT03391401
• Lead Sponsor: St. Franziskus Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-05
• Study Start: 2018-03-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-07-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adip1	Bariatric surgery	Patients with morbid obesity (i.e. BMI \>35 kg/sqm) and age \>18 scheduled for bariatric surgery (all standard procedures included)

Primary Outcome Measures

Name	Time	Method
Changes of microbiome after bariatric surgery	at time of operation, 3 and 6 months after the operation	Collection of blood sample before and after (3 and 6 months) the operation

Secondary Outcome Measures

Name	Time	Method
incidence of fatty liver in obese patients	during the operation	Surgical liver biopsy during laparoscopy

Trial Locations

Locations (2)

University of Bonn; 🇩🇪 Bonn, Germany

St. Franziskus-Hospital; 🇩🇪 Cologne, Germany