Clinical trial NCT03391401: Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery
Official title: Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
NAFLD
Microbiome
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
Collaborators: name: University of Bonn
First posted: 2018-01-05
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Patients with the above given criteria that are willing to treat their morbid obesity by bariatric surgery and have at least absolved 3 months of failed conservative treatment for morbid obesity, have shown to have good long-time compliance and high motivation.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of microbiome after bariatric surgery
timeFrame: at time of operation, 3 and 6 months after the operation
measure: Changes of microbiome after bariatric surgery
timeFrame: at time of operation, 3 and 6 months after the operation
Secondary outcomes:
measure: incidence of fatty liver in obese patients
timeFrame: during the operation
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
city: Cologne
country: Germany
facility: St. Franziskus-Hospital
Study officials:
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