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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polycystic ovary syndrome (PCOS)+ insulin resistance (IR) |
| ||
| Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR) |
| ||
| No PCOS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of interleukin-6 (il-6) concentration in blood serum | Diagnostic Test | Measurement of fasting interleukin-6 (il-6) concentration in fasting venous blood serum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Il-6 concentration | Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in [pg/ml] in three research groups | up to 6 months |
| Il-18 concentration | Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in [pg/ml] in three research groups | up to 6 months |
| Il-4 concentration | Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in [pg/ml] in three research groups | up to 6 months |
| TNF-α concentration | Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in [pg/ml] in three research groups | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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women aged 18-45 years, managed for menstrual irregularities, infertility or for routine check-up
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iwona Gawron, Ph.D., M.D. | Contact | +48 124248570 | iwona.gawron@uj.edu.pl | |
| Robert Jach, Prof., Ph.D., M.D. | Contact | jach@cm-uj.krakow.pl |
| Name | Affiliation | Role |
|---|---|---|
| Kazimierz Pityński, Prof., Ph.D., M.D. | Jagiellonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University | Recruiting | Krakow | Poland |
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blood serum samples
| Measurement of fasting tumor necrosis factor α (TNF-α) concentration | Diagnostic Test | Measurement of fasting tumor necrosis factor α concentration in fasting venous blood serum |
|
| Measurement of interleukin-18 (il-18) concentration | Diagnostic Test | Measurement of interleukin-18 (il-18) concentration in fasting venous blood serum |
|
| Measurement of interleukin-4 (il-4) concentration | Diagnostic Test | Measurement of interleukin-4 (il-4) concentration in fasting venous blood plasma |
|
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D008599 | Menstruation Disturbances |
| D007333 | Insulin Resistance |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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