Viewing Study NCT04540263



Ignite Creation Date: 2024-05-06 @ 3:10 PM
Last Modification Date: 2025-12-17 @ 7:05 AM
Study NCT ID: NCT04540263
Status: None
Last Update Posted: 2021-07-27 00:00:00
First Post: 2020-09-03 00:00:00

Brief Title: Cytokine Levels of Patients Who Underwent Obesity Surgery
Sponsor: Istanbul Training and Research Hospital
Organization: Istanbul Training and Research Hospital

Study Overview

Official Title: Evaluation of Blood Cytokine Levels of Patients Who Underwent Sleeve Gastrectomy and Gastric Bypass Operations Due to Obesity
Status: None
Status Verified Date: 2021-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.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
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 syndromeThere 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 patientsWe 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None