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Circulating IL-6, Clusterin and Irisin in Obese Subjects

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ClinicalTrials.gov Identifier: NCT04133896
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Rehab Werida, Damanhour University

Brief 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.

Condition or disease Intervention/treatment
Obesity 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.


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Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Circulating IL-6, Clusterin and Irisin in Obese Subjects With Different Grades of Obesity: Association With Insulin Resistance and Sexual Dimorphism
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 30, 2019

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




Primary Outcome Measures :
  1. insulin resistance [ Time Frame: 18 months ]
    by homeostasis insulin resistance index (fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 )

  2. IL- 6 [ Time Frame: 18 Months ]
    blood level of IL-6

  3. Clusterin [ Time Frame: 18 Months ]
    blood level of Clusterin

  4. Irisin [ Time Frame: 18 Months ]
    blood level of Irisin

  5. Lipid profile [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   based on self-representation of gender identity.
Accepts Healthy Volunteers:   No
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133896


Locations
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Egypt
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Sponsors and Collaborators
Rehab Werida
Tanta University
Investigators
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Principal Investigator: Rehab H Werida, Lecturer Damanhour University, Faculty of Pharmacy

Publications of Results:
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Responsible Party: Rehab Werida, Clinical Pharmacy Lecturer, Damanhour University
ClinicalTrials.gov Identifier: NCT04133896     History of Changes
Other Study ID Numbers: Obesity and IR
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms