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

Sponsor
St. Franziskus Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03391401
Collaborator
University of Bonn (Other)
204
Enrollment
2
Locations
41
Actual Duration (Months)
102
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery

Study Design

Study Type:
Observational
Actual Enrollment :
204 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Adip1

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).

Outcome Measures

Primary Outcome Measures

  1. Changes of microbiome after bariatric surgery [at time of operation, 3 and 6 months after the operation]

    Collection of stool sample before and after (3 and 6 months) the operation

  2. 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

  1. incidence of fatty liver in obese patients [during the operation]

    Surgical liver biopsy during laparoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Bonn Bonn Germany 53127
2 St. Franziskus-Hospital Cologne Germany 50825

Sponsors and Collaborators

  • St. Franziskus Hospital
  • University of Bonn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andreas Plamper, Assistant study director, St. Franziskus Hospital
ClinicalTrials.gov Identifier:
NCT03391401
Other Study ID Numbers:
  • 2017110
First Posted:
Jan 5, 2018
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity
Obesity, Morbid

Study Results

No Results Posted as of Oct 7, 2021