Chronic Inflammation After Obesity Surgery

July 29, 2018 updated by: Sonja Chiappetta, MD, Sana Klinikum Offenbach

Impact of Obesity and Metabolic Surgery on Chronic Inflammation

To evaluate the impact of obesity surgery on chronic inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • acute inflammation during laboratory examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
laparoscopic sleeve gastrectomy
patients who underwent laparoscopic sleeve gastrectomy (LSG) due to obesity and/or metabolic syndrome
Other: Laboratory Examination
Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB
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
Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB
laparoscopic omega-loop gastric bypass
patients who underwent laparoscopic omega-loop gastric bypass (LOLGB) due to obesity and/or metabolic syndrome
Other: Laboratory Examination
Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic inflammation
Time Frame: 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
one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty liver index
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Liver enzymes
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Body Mass Index (BMI) in kg/m²
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
weight in kg
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
waist circumference
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
HbA1c
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Chronic inflammation II
Time Frame: 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
one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Acute inflammation
Time Frame: one day preoperatively and one and four days postoperatively
the changing of c-reactive protein in mg/l after obesity surgery
one day preoperatively and one and four days postoperatively
Acute inflammation II
Time Frame: one day preoperatively and one and four days postoperatively
the changing of leucocytes in /nl after obesity surgery
one day preoperatively and one and four days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Klinikum Offenbach

Investigators

  • Study Chair: Rudolf Weiner, MD, Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 20, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 29, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF 145/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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