NCT03391401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

2.9 years

First QC Date

December 7, 2017

Last Update Submit

October 6, 2021

Conditions

Obesity, MorbidBariatric Surgery CandidateNAFLDMicrobiome

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • incidence of fatty liver in obese patients

    during the operation

Study Arms (1)

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

Interventions

Bariatric surgeryPROCEDURE

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).

Adip1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Bonn

Bonn, 53127, Germany

Location

St. Franziskus-Hospital

Cologne, 50825, Germany

Location

Related Publications (8)

  • Li Z, Bowerman S, Heber D. Health ramifications of the obesity epidemic. Surg Clin North Am. 2005 Aug;85(4):681-701, v. doi: 10.1016/j.suc.2005.04.006.

    PMID: 16061080RESULT

  • 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. doi: 10.1136/bmj.39367.495995.AE. Epub 2007 Nov 6.

    PMID: 17986716RESULT

  • Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914.

    PMID: 22215166RESULT

  • 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.

    PMID: 24042449RESULT

  • 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. doi: 10.1001/jama.292.14.1724.

    PMID: 15479938RESULT

  • 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 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.

    PMID: 22297845RESULT

  • 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. doi: 10.1172/JCI86674. Epub 2016 Oct 24.

    PMID: 27775551RESULT

  • 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.

    PMID: 23747244RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Hair samples, blood samples

MeSH Terms

Conditions

Obesity, MorbidNon-alcoholic Fatty Liver Disease

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant study director

Study Record Dates

First Submitted

December 7, 2017

First Posted

January 5, 2018

Study Start

March 1, 2018

Primary Completion

January 31, 2021

Study Completion

July 31, 2021

Last Updated

October 7, 2021

Record last verified: 2021-10

Locations

DE(2)