Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS
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
Iwona Magdalena Gawron
PhD, MD, Principal Investigator
Jagiellonian University
