NCT04540263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

September 3, 2020

Last Update Submit

July 25, 2021

Conditions

Obesity

Keywords

Sleeve GastrectomyGastric bypassFlow-cytometryCytokine

Outcome Measures

Primary Outcomes (1)

  • Cytokine levels

    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 Outcomes (1)

  • Weight changes

    6 months

Study Arms (2)

Sleeve Gastrectomy

Patients who underwent Sleeve gastrectomy operation

Diagnostic Test: Flow Cytometric analysis

Gastric Bypass

Patients who underwent Gastric Bypass operation

Diagnostic Test: Flow Cytometric analysis

Interventions

Flow Cytometric analysisDIAGNOSTIC_TEST

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 BypassSleeve Gastrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31508889BACKGROUND

  • 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.

    PMID: 28569359BACKGROUND

  • 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. doi: 10.3945/ajcn.115.115592. Epub 2016 Aug 24.

    PMID: 27557657BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ufuk Oguz Idiz, Assoc.Prof.

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 7, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

TU(1)