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Cytokine Levels of Patients Who Underwent Obesity Surgery

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ClinicalTrials.gov Identifier: NCT04540263
Recruitment Status : Completed
First Posted : September 7, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ufuk Oguz Idiz, Istanbul Training and Research Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Obesity Diagnostic Test: Flow Cytometric analysis

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Blood Cytokine Levels of Patients Who Underwent Sleeve Gastrectomy and Gastric Bypass Operations Due to Obesity
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : July 1, 2021
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Weight changes [ Time Frame: 6 months ]
    The weight changes over time after the surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540263


Locations
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Turkey
Istanbul Training and Research Hospital
Istanbul, Turkey, 34371
Sponsors and Collaborators
Istanbul Training and Research Hospital
Investigators
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Principal Investigator: Ufuk Oguz Idiz, Assoc.Prof. Istanbul Training and Research Hospital
More Information
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Publications:

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Responsible Party: Ufuk Oguz Idiz, Assoc. Prof. MD, Istanbul Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04540263    
Other Study ID Numbers: Obesity Cytokine
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ufuk Oguz Idiz, Istanbul Training and Research Hospital:
Sleeve Gastrectomy
Gastric bypass
Flow-cytometry
Cytokine
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight