Chronic Inflammation After Obesity Surgery

Completed

• Conditions: Obesity
• Interventions: Other: Laboratory Examination

• Registration Number: NCT02697695
• Lead Sponsor: Sana Klinikum Offenbach

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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-12
• Study Completion: 2016-02
• Study First Submitted: 2016-02-20
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-29
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• acute inflammation during laboratory examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic sleeve gastrectomy	Laboratory Examination	patients who underwent laparoscopic sleeve gastrectomy (LSG) due to obesity and/or metabolic syndrome
laparoscopic Roux-en-Y- gastric bypass	Laboratory Examination	patients who underwent laparoscopic Roux-en-Y- gastric bypass (LRYGB) due to obesity and/or metabolic syndrome
laparoscopic omega-loop gastric bypass	Laboratory Examination	patients who underwent laparoscopic omega-loop gastric bypass (LOLGB) due to obesity and/or metabolic syndrome

Primary Outcome Measures

Name	Time	Method
Chronic inflammation	one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively	the changing of leucocytes in /nl after obesity surgery

Secondary Outcome Measures

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