Circulating IL-6, Clusterin and Irisin in Obese Subjects

NCT04133896 — Completed, 176 participants, Rehab Werida

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Circulating IL-6, Clusterin and Irisin in Obese Subjects With Different Grades of Obesity: Association With Insulin Resistance and Sexual Dimorphism

RegistryNCT04133896
StatusCompleted
Study typeObservational
Enrollment176 (Actual)
SponsorRehab Werida (Other); collaborators: Tanta University
ConditionsObesity
InterventionsIL-6, Clusterin, Irisin Level (Diagnostic test)
Datesstart 2018-02-01, primary completion 2019-06-01, completion 2019-06-30, first posted 2019-10-21, last updated 2019-10-22
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials of IL-6, Clusterin, Irisin Level

-Summary

evaluate the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and their sexual dimorphism also identify the association of IL-6, clusterin and irisin with insulin resistance.

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+Detailed description

Aim: Firstly, this study aimed at assessing the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and evaluating their sexual dimorphism and secondly evaluate the association of IL-6, clusterin and irisin with insulin resistance.

Method: This study was conducted on 176 non-diabetic subjects of both sexes. Participants were classified according to their sex into two groups; the male and female groups. The male group (88 men) was classified according to BMI into; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22 class II obese men), and group 4 (22 class III obese men). The female group (88 women) was also classified according to BMI exactly as the male group. Fasting blood glucose, fasting insulin, lipid panel, serum IL-6, clusterin and irisin levels were measured. One-way analysis of variance followed by Tukey's as post hoc test was used for comparison of variables.

+Arms and interventions

ArmTypeInterventionsDescription
Group 1 MaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 1 (22 lean men),
Group 2 MaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 2 (22 class I obese men),
Group 3 MaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 3 (22class II obese men),
Group 4 MaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 4 (22 class III obese men).
Group 1 FemaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 1 (22 lean women),
Group 2 FemaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 2 (22 class I obese women),
Group 3 FemaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 3 (22 class II obese women),
Group 4 FemaleDiagnostic Test: IL-6, Clusterin, Irisin Levelgroup 4 (22 class III obese women).
  • IL-6, Clusterin, Irisin Level (Diagnostic test): Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

+Outcome measures

Primary outcomes

  • insulin resistance [18 months]: by homeostasis insulin resistance index (fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 )
  • IL- 6 [18 Months]: blood level of IL-6
  • Clusterin [18 Months]: blood level of Clusterin
  • Irisin [18 Months]: blood level of Irisin
  • Lipid profile [18 Months]: Plasma triglycerides and total cholesterol were measured by enzymatic colorimetric method. High-density lipoprotein cholesterol (HDL-C) was measured by precipitation method. Low density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula

+Eligibility

Sex: All, ages: 20 Years to 45 Years

Inclusion Criteria:

* Healthy Female and Male
* Age matched adult non-diabetic non-smoker males and females'

Exclusion Criteria:

* smokers, subjects with a history of diabetes mellitus, liver, renal, thyroid, inflammatory diseases, and females on contraceptives pills. Patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, anti-hyperlipidemics, non-selective beta blockers, thiazides, etc.) and subjects with organic causes of obesity were also excluded from this study.

+Locations (1)

FacilityCityCountryStatus
Tanta UniversityTanta, El-GharbiaEgypt

+Publications

  • Results publication: Gouni-Berthold I, Berthold HK, Huh JY, Berman R, Spenrath N, Krone W, Mantzoros CS. Effects of lipid-lowering drugs on irisin in human subjects in vivo and in human skeletal muscle cells ex vivo. PLoS One. 2013 Sep 2;8(9):e72858. doi: 10.1371/journal.pone.0072858. eCollection 2013. PMID 24023786
  • Results publication: Baralla A, Sotgiu E, Deiana M, Pasella S, Pinna S, Mannu A, Canu E, Sotgiu G, Ganau A, Zinellu A, Sotgia S, Carru C, Deiana L. Plasma Clusterin and Lipid Profile: A Link with Aging and Cardiovascular Diseases in a Population with a Consistent Number of Centenarians. PLoS One. 2015 Jun 15;10(6):e0128029. doi: 10.1371/journal.pone.0128029. eCollection 2015. PMID 26076476
  • Results publication: van Greevenbroek MM, Schalkwijk CG, Stehouwer CD. Obesity-associated low-grade inflammation in type 2 diabetes mellitus: causes and consequences. Neth J Med. 2013 May;71(4):174-87. PMID 23723111

+Investigators