Cytokine Levels of Patients Who Underwent Obesity Surgery

July 25, 2021 updated by: Ufuk Oguz Idiz, Istanbul Training and Research Hospital

Evaluation of Blood Cytokine Levels of Patients Who Underwent Sleeve Gastrectomy and Gastric Bypass Operations Due to Obesity

Obesity is an important public health problem worldwide. There are large regional differences in the prevalence of overweight and obesity. Obesity is a growing problem in both developed and low-income countries. Obesity is a common condition characterized by excessive fat accumulation in adipose tissue. It is associated with metabolic, hematological and musculoskeletal complications, increased risk of dyslipidemia, heart disease, diabetes and some malignancies, leading to a shortened life span. Inflammation from adipose tissue has been identified as the main source of systemic inflammation and may also be associated with insulin resistance. Adipocytes and adipose tissue-related macrophages from obese individuals are an important source of inflammatory mediators such as TNF-α, IL-6, IL-1 and MCP-1. It has also been shown that decreased levels of IL-10, an anti-inflammatory cytokine, are associated with obesity and metabolic syndrome.We aimed to evaluate changes in 13 different proinflammatory and anti-inflammatory cytokines in patients who underwent sleeve gastrectomy or gastric bypass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is an important public health problem worldwide. There are large regional differences in the prevalence of overweight and obesity. Obesity is a growing problem in both developed and low-income countries. Obesity is a common condition characterized by excessive fat accumulation in adipose tissue. It is associated with metabolic, hematological and musculoskeletal complications, increased risk of dyslipidemia, heart disease, diabetes and some malignancies, leading to a shortened life span. Inflammation from adipose tissue has been identified as the main source of systemic inflammation and may also be associated with insulin resistance. Adipocytes and adipose tissue-related macrophages from obese individuals are an important source of inflammatory mediators such as TNF-α, IL-6, IL-1 and MCP-1. It has also been shown that decreased levels of IL-10, an anti-inflammatory cytokine, are associated with obesity and metabolic syndrome.There are many studies examining the changes in the weight and blood values of patients after bariatric surgery. Among these blood values, cytokines, which are inflammation mediators, were evaluated. However, in these studies, either sleeve gastrectomy or gastric bypass was evaluated separately and generally focused on TNF-α, IL-6, IL-1, IL10, and MCP-1 cytokines. There are conflicting results regarding the parameters examined in these studies. In some studies, no difference was found in the cytokines examined, while some regression was observed in proinflammatory cytokines. The situation is similar for IL10, which is one of the anti-inflammatory cytokines. An increase in IL10 values was observed in a study evaluating patients who underwent gastritic bypass, whereas no difference was found in a study evaluating sleeve gastrectomy patients.We aimed to evaluate changes in 13 different proinflammatory and anti-inflammatory cytokines before and 6 month after the surgery in patients who underwent sleeve gastrectomy or gastric bypass

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34371
        • Istanbul Training and Research Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had >35 body mass index and had obesity surgery (sleeve gastrectomy, gastric bypass) will be included

Description

Inclusion Criteria:

  • Patients who had sleeve gastrectomy or gastric bypass due to obesity

Exclusion Criteria:

  • Cancer patients,
  • Pregnant women,
  • Have a history of immunodeficiency
  • Patients with previous obesity surgery

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sleeve Gastrectomy
Patients who underwent Sleeve gastrectomy operation
Diagnostic test: Flow Cytometric analysis
Measuring the level of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokines in the serum
Gastric Bypass
Patients who underwent Gastric Bypass operation
Diagnostic test: Flow Cytometric analysis
Measuring the level of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokines in the serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine levels
Time Frame: 6 months
Serum IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight changes
Time Frame: 6 months
The weight changes over time after the surgery
6 months

Collaborators and Investigators

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

Sponsor

Istanbul Training and Research Hospital

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 (Actual)

June 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity Cytokine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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