NCT02697695

Brief Summary

To evaluate the impact of obesity surgery on chronic inflammation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

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

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

February 20, 2016

Last Update Submit

July 29, 2018

Conditions

Obesity

Keywords

chronic inflammationfatty liver index

Outcome Measures

Primary Outcomes (1)

  • Chronic inflammation

    the changing of leucocytes in /nl after obesity surgery

    one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively

Secondary Outcomes (9)

  • Fatty liver index

    one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively

  • Liver enzymes

    one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively

  • Body Mass Index (BMI) in kg/m²

    one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively

  • weight in kg

    one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively

  • waist circumference

    one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively

  • +4 more secondary outcomes

Study Arms (3)

laparoscopic sleeve gastrectomy

patients who underwent laparoscopic sleeve gastrectomy (LSG) due to obesity and/or metabolic syndrome

Other: Laboratory Examination

laparoscopic Roux-en-Y- gastric bypass

patients who underwent laparoscopic Roux-en-Y- gastric bypass (LRYGB) due to obesity and/or metabolic syndrome

Other: Laboratory Examination

laparoscopic omega-loop gastric bypass

patients who underwent laparoscopic omega-loop gastric bypass (LOLGB) due to obesity and/or metabolic syndrome

Other: Laboratory Examination

Interventions

Laboratory ExaminationOTHER

Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB

laparoscopic Roux-en-Y- gastric bypasslaparoscopic omega-loop gastric bypasslaparoscopic sleeve gastrectomy

Eligibility Criteria

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

Patients who underwent LSG, LRYGB, LOLGB due to obesity and/or metabolic syndrome

You may qualify if:

  • BMI \> 35kg/m² and obesity-related disease or BMI \> 40kg/m²

You may not qualify if:

  • acute inflammation during laboratory examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. doi: 10.1038/nature05485.

    PMID: 17167474RESULT

  • Nijhuis J, Rensen SS, Slaats Y, van Dielen FM, Buurman WA, Greve JW. Neutrophil activation in morbid obesity, chronic activation of acute inflammation. Obesity (Silver Spring). 2009 Nov;17(11):2014-8. doi: 10.1038/oby.2009.113. Epub 2009 Apr 23.

    PMID: 19390527RESULT

  • Morshed G, Fathy SM. Impact of post-laparoscopic sleeve gastrectomy weight loss on C-reactive protein, lipid profile and CA-125 in morbidly obese women. Wideochir Inne Tech Maloinwazyjne. 2016 Jan;10(4):521-6. doi: 10.5114/wiitm.2015.56480. Epub 2015 Dec 15.

    PMID: 26865887RESULT

  • Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.

    PMID: 15864338RESULT

  • Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.

    PMID: 15599400RESULT

  • Chiappetta S, Schaack HM, Wolnerhannsen B, Stier C, Squillante S, Weiner RA. The Impact of Obesity and Metabolic Surgery on Chronic Inflammation. Obes Surg. 2018 Oct;28(10):3028-3040. doi: 10.1007/s11695-018-3320-y.

    PMID: 29876839DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rudolf Weiner, MD

    Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sonja Chiappetta

Study Record Dates

First Submitted

February 20, 2016

First Posted

March 3, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share