Circulating IL-6, Clusterin and Irisin in Obese Subjects

NCT ID: NCT04133896

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1 Male

group 1 (22 lean men),

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 2 Male

group 2 (22 class I obese men),

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 3 Male

group 3 (22class II obese men),

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 4 Male

group 4 (22 class III obese men).

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 1 Female

group 1 (22 lean women),

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 2 Female

group 2 (22 class I obese women),

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 3 Female

group 3 (22 class II obese women),

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Group 4 Female

group 4 (22 class III obese women).

IL-6, Clusterin, Irisin Level

Intervention Type DIAGNOSTIC_TEST

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Interventions

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IL-6, Clusterin, Irisin Level

Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Rehab Werida

OTHER

Sponsor Role lead

Responsible Party

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Rehab Werida

Clinical Pharmacy Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rehab H Werida, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Damanhour University, Faculty of Pharmacy

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 24023786 (View on PubMed)

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.

Reference Type RESULT
PMID: 26076476 (View on PubMed)

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.

Reference Type RESULT
PMID: 23723111 (View on PubMed)

Other Identifiers

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Obesity and IR

Identifier Type: -

Identifier Source: org_study_id

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