Cytokine Levels of Patients Who Underwent Obesity Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540263
• Other study ID #: Obesity Cytokine
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Diagnostic Test:
• Flow Cytometric analysis
Measuring the level of IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokines in the serum

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Cepeda-Lopez AC, Allende-Labastida J, Melse-Boonstra A, Osendarp SJ, Herter-Aeberli I, Moretti D, Rodriguez-Lastra R, Gonzalez-Salazar F, Villalpando S, Zimmermann MB. The effects of fat loss after bariatric surgery on inflammation, serum hepcidin, and iron absorption: a prospective 6-mo iron stable isotope study. Am J Clin Nutr. 2016 Oct;104(4):1030-1038. Epub 2016 Aug 24. — View Citation

Salman MA, Salman AA, Nafea MA, Sultan AAEA, Anwar HW, Ibrahim AH, Awad A, Ahmed RA, Seif El Nasr SM, Abouelregal TE, Shaaban HE, Mohamed FAH. Study of changes of obesity-related inflammatory cytokines after laparoscopic sleeve gastrectomy. ANZ J Surg. 2019 Oct;89(10):1265-1269. doi: 10.1111/ans.15427. Epub 2019 Sep 11. — View Citation

Shimizu H, Hatao F, Imamura K, Takanishi K, Tsujino M. Early Effects of Sleeve Gastrectomy on Obesity-Related Cytokines and Bile Acid Metabolism in Morbidly Obese Japanese Patients. Obes Surg. 2017 Dec;27(12):3223-3229. doi: 10.1007/s11695-017-2756-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytokine levels	Serum IL-1ß, IFN-a2, IFN-?, TNF-a, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels	6 months
Secondary	Weight changes	The weight changes over time after the surgery	6 months