Circulating IL-6, Clusterin and Irisin in Obese Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Diagnostic test: IL-6, Clusterin, Irisin Level

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.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects included in the study were classified according to their sex into two main group the male group and the female group. The male group contained 88 men which subdivided according to the BMI into the following groups; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22class II obese men), and group 4 (22 class III obese men). The female group contained 88 adult women which sub-classified according to BMI into the following subgroups; group 1 (22 lean women), group 2 (22 class I obese women), group 3 (22 class II obese women), and group 4 (22 class III obese women).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 Male; group 1 (22 lean men),	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 2 Male; group 2 (22 class I obese men),	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 3 Male; group 3 (22class II obese men),	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 4 Male; group 4 (22 class III obese men).	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 1 Female; group 1 (22 lean women),	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 2 Female; group 2 (22 class I obese women),	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 3 Female; group 3 (22 class II obese women),	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
Group 4 Female; group 4 (22 class III obese women).	Diagnostic test: IL-6, Clusterin, Irisin Level; Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin resistance	by homeostasis insulin resistance index (fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 )	18 months
IL- 6	blood level of IL-6	18 Months
Clusterin	blood level of Clusterin	18 Months
Irisin	blood level of Irisin	18 Months
Lipid profile	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	18 Months

Collaborators and Investigators

• Sponsor: Rehab Werida
• Collaborators: Tanta University
• Investigators: Principal Investigator: Rehab H Werida, Lecturer, Damanhour University, Faculty of Pharmacy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Obesity and IR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No