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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity, Morbid Bariatric Surgery Candidate NAFLD Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adip1

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

Bariatric surgery

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No