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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391401
• Other study ID #: 2017110
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2021
• Source: St. Franziskus Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Microbiome
• NAFLD
• Obesity
• Obesity, Morbid

Intervention

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).

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn
Germany	St. Franziskus-Hospital	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
St. Franziskus Hospital	University of Bonn

Country where clinical trial is conducted

Germany, 

References & Publications (8)

Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728. — View Citation

Fujisaka S, Ussar S, Clish C, Devkota S, Dreyfuss JM, Sakaguchi M, Soto M, Konishi M, Softic S, Altindis E, Li N, Gerber G, Bry L, Kahn CR. Antibiotic effects on gut microbiota and metabolism are host dependent. J Clin Invest. 2016 Dec 1;126(12):4430-4443 — View Citation

Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 — View Citation

Li Z, Bowerman S, Heber D. Health ramifications of the obesity epidemic. Surg Clin North Am. 2005 Aug;85(4):681-701, v. Review. — View Citation

Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17. Review. — View Citation

Mathis D. Immunological goings-on in visceral adipose tissue. Cell Metab. 2013 Jun 4;17(6):851-859. doi: 10.1016/j.cmet.2013.05.008. Review. — View Citation

Reeves GK, Pirie K, Beral V, Green J, Spencer E, Bull D; Million Women Study Collaboration. Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study. BMJ. 2007 Dec 1;335(7630):1134. Epub 2007 Nov 6. — View Citation

Sjöström L, Peltonen M, Jacobson P, Sjöström CD, Karason K, Wedel H, Ahlin S, Anveden Å, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lönroth H, Narbro K, Näslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric su — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of microbiome after bariatric surgery	Collection of stool sample before and after (3 and 6 months) the operation	at time of operation, 3 and 6 months after the operation
Primary	Changes of microbiome after bariatric surgery	Collection of blood sample before and after (3 and 6 months) the operation	at time of operation, 3 and 6 months after the operation
Secondary	incidence of fatty liver in obese patients	Surgical liver biopsy during laparoscopy	during the operation