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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03391401
Other study ID # 2017110
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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