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

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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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Body Weight Digestive System Diseases Fatty Liver Liver Diseases Microbiome NAFLD Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bonn, Bonn, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

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).

Primary outcomes

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

Secondary outcomes

incidence of fatty liver in obese patients

Time frame: during the operation

Surgical liver biopsy during laparoscopy

Sponsors and collaborators

Lead sponsor

St. Franziskus Hospital

Other

Collaborators

University of Bonn

Registry information

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jan 5, 2018
Registry last updated: Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed