Clinical trial NCT02697695: Chronic Inflammation After Obesity Surgery
Official title: Impact of Obesity and Metabolic Surgery on Chronic Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: chronic inflammation
fatty liver index
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent LSG, LRYGB, LOLGB due to obesity and/or metabolic syndrome

Brief summary: To evaluate the impact of obesity surgery on chronic inflammation.

Detailed description: A retrospective study to compare the impact of laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en Y- gastric bypass (LRYGB) and laparoscopic omega-loop gastric bypass (LOLGB) on chronic inflammation and metabolic syndrome.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* acute inflammation during laboratory examination

Primary outcomes:
measure: Chronic inflammation
timeFrame: one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary outcomes:
measure: Fatty liver index
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: Liver enzymes
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: Body Mass Index (BMI) in kg/m²
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: weight in kg
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: waist circumference
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: HbA1c
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: Chronic inflammation II
timeFrame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
measure: Acute inflammation
timeFrame: one day preoperatively and one and four days postoperatively
measure: Acute inflammation II
timeFrame: one day preoperatively and one and four days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery
name: Rudolf Weiner, MD
role: STUDY_CHAIR
References:
citation: Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. doi: 10.1038/nature05485.
citation: 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.
citation: 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.
citation: Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
citation: 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.
citation: 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.