Chronic Inflammation After Obesity Surgery

Obesity Clinical Trial

Official title:

Impact of Obesity and Metabolic Surgery on Chronic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697695
• Other study ID #: FF 145/2015
• Status: Completed
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: July 2018
• Source: Sana Klinikum Offenbach
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the impact of obesity surgery on chronic inflammation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• acute inflammation during laboratory examination

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sana Klinikum Offenbach

References & Publications (5)

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. — View Citation

Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. Review. — View 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 — View 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. — View Citation

Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatty liver index	the changing of fatty liver index after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	Liver enzymes	the changing of GOT in U/l, GPT in U/l, GGT in U/l, AP in U/l after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	Body Mass Index (BMI) in kg/m²	the changing of BMI in kg/m² before and after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	weight in kg	the changing of weight before and after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	waist circumference	the changing of waist circumference in cm before and after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	HbA1c	the changing of HbA1c in % and after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	Chronic inflammation II	the changing of c-reactive protein in mg/l after obesity surgery	one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary	Acute inflammation	the changing of c-reactive protein in mg/l after obesity surgery	one day preoperatively and one and four days postoperatively
Secondary	Acute inflammation II	the changing of leucocytes in /nl after obesity surgery	one day preoperatively and one and four days postoperatively