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Clinical Trials/NCT06793085
NCT06793085RecruitingNot Applicable

Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS

Jagiellonian University1 site in 1 country100 target enrollmentStarted: January 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Il-6 concentration

Study Overview

Brief Summary

The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Detailed Description

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.

The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •women aged 18-45 years

Exclusion Criteria

  • •previous removal of at least one ovary
  • •treated diabetes of any type
  • •diagnosed and treated metabolic diseases
  • •diagnosed and treated autoimmune diseases
  • •diagnosed and treated autoinflammatory diseases

Arms & Interventions

No PCOS

Intervention: Measurement of interleukin-4 (il-4) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

Intervention: Measurement of interleukin-18 (il-18) concentration (Diagnostic Test)

No PCOS

Intervention: Measurement of interleukin-18 (il-18) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

Intervention: Measurement of interleukin-6 (il-6) concentration in blood serum (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

Intervention: Measurement of fasting tumor necrosis factor α (TNF-α) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

Intervention: Measurement of interleukin-18 (il-18) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

Intervention: Measurement of interleukin-4 (il-4) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

Intervention: Measurement of interleukin-6 (il-6) concentration in blood serum (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

Intervention: Measurement of fasting tumor necrosis factor α (TNF-α) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

Intervention: Measurement of interleukin-4 (il-4) concentration (Diagnostic Test)

No PCOS

Intervention: Measurement of interleukin-6 (il-6) concentration in blood serum (Diagnostic Test)

No PCOS

Intervention: Measurement of fasting tumor necrosis factor α (TNF-α) concentration (Diagnostic Test)

Outcomes

Primary Outcomes

Il-6 concentration

Time Frame: up to 6 months

Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in \[pg/ml\] in three research groups

Il-18 concentration

Time Frame: up to 6 months

Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in \[pg/ml\] in three research groups

Il-4 concentration

Time Frame: up to 6 months

Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in \[pg/ml\] in three research groups

TNF-α concentration

Time Frame: up to 6 months

Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in \[pg/ml\] in three research groups

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Jagiellonian University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Iwona Magdalena Gawron

PhD, MD, Principal Investigator

Jagiellonian University

Study Sites (1)

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