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Trial record 10 of 27 for:    15479938 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03391401
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
University of Bonn
Information provided by (Responsible Party):
Andreas Plamper, St. Franziskus Hospital

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
Obesity, Morbid Bariatric Surgery Candidate NAFLD Microbiome Procedure: Bariatric surgery

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Study Type : Observational
Estimated Enrollment : 400 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 : March 1, 2018
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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).




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. incidence of fatty liver in obese patients [ Time Frame: during the operation ]
    Surgical liver biopsy during laparoscopy


Biospecimen Retention:   Samples With DNA
Hair samples, blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Karl P Rheinwalt, MD +49-5591 ext 1128 karlpeter.rheinwalt@cellitinnen.de
Contact: Andreas Plamper, MD +49-5591 ext 1126 andreas.plamper@cellitinnen.de

Locations
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Germany
University of Bonn Active, not recruiting
Bonn, Germany, 53127
St. Franziskus-Hospital Recruiting
Cologne, Germany, 50825
Contact: Karl P Rheinwalt, MD    +49-221-5591 ext 1128    karlpeter.rheinwalt@cellitinnen.de   
Contact: Andreas Plamper, MD    +49-221-5591 ext 1126    andreas.plamper@cellitinnen.de   
Sponsors and Collaborators
St. Franziskus Hospital
University of Bonn

Publications of Results:

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Responsible Party: Andreas Plamper, Assistant study director, St. Franziskus Hospital
ClinicalTrials.gov Identifier: NCT03391401     History of Changes
Other Study ID Numbers: 2017110
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms