Circulating IL-6, Clusterin and Irisin in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133896
• Other study ID #: Obesity and IR
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: October 2019
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Diagnostic Test:
• IL-6, Clusterin, Irisin Level
Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Rehab Werida	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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 Ce — View Citation

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 — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin resistance	by homeostasis insulin resistance index (fasting insulin (µIU/ml) times fasting glucose (mg/L) divided by 405 )	18 months
Primary	IL- 6	blood level of IL-6	18 Months
Primary	Clusterin	blood level of Clusterin	18 Months
Primary	Irisin	blood level of Irisin	18 Months
Primary	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