Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03391401|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : August 1, 2018
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.
|Condition or disease||Intervention/treatment|
|Obesity, Morbid Bariatric Surgery Candidate NAFLD Microbiome||Procedure: Bariatric surgery|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||January 15, 2020|
|Estimated Study Completion Date :||July 15, 2020|
Patients with morbid obesity (i.e. BMI >35 kg/sqm) and age >18 scheduled for bariatric surgery (all standard procedures included)
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).
- Changes of microbiome after bariatric surgery [ Time Frame: at time of operation, 3 and 6 months after the operation ]Collection of stool sample before and after (3 and 6 months) the operation
- Changes of microbiome after bariatric surgery [ Time Frame: at time of operation, 3 and 6 months after the operation ]Collection of blood sample before and after (3 and 6 months) the operation
- incidence of fatty liver in obese patients [ Time Frame: during the operation ]Surgical liver biopsy during laparoscopy
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391401
|Contact: Karl P Rheinwalt, MD||+49-5591 ext email@example.com|
|Contact: Andreas Plamper, MD||+49-5591 ext firstname.lastname@example.org|
|University of Bonn||Active, not recruiting|
|Bonn, Germany, 53127|
|Cologne, Germany, 50825|
|Contact: Karl P Rheinwalt, MD +49-221-5591 ext 1128 email@example.com|
|Contact: Andreas Plamper, MD +49-221-5591 ext 1126 firstname.lastname@example.org|