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The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy among reproductive-age women, characterized primarily by insulin resistance (IR), which has a prevalence of 35% to 80%. Metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The hyperinsulinemic-euglycemic clamp study is regarded as the gold standard for assessing insulin sensitivity; however, its clinical application is limited. Alternative assessments, such as the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin or glucose tolerance tests, provide limited clinical utility. Therefore, there is a pressing need for the identification of more precise and universal markers of insulin resistance. There is a need to elucidate the precise role of adipokines in the etiology of PCOS and their association with insulin resistance, which is responsible for the development of adverse health-related complications.
The aim of the study is to measure and compare the concentrations of selected adipokines: leptin, resistin, omentin-1 across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.
The tests will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer.
The concentrations of the investigated substances will be measured and compared within the three research groups.
Statistical analysis will be conducted using SPSS Statistics software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCOS+IR | Polycystic ovary syndrome + insulin resistance |
| |
| PCOS + no IR | Polycystic ovary syndrome + no insulin resistance |
| |
| No PCOS | Women without PCOS (control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptin concentration in blood serum | Diagnostic Test | Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of resistin concentration in three study groups | Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups | up to 6 months |
| Comparison of leptin concentration three study groups | Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups | up to 6 months |
| Comparison of omentin-1 concentration in three study groups | Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study 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 or 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 | +48 124248570 | jach@cm-uj.krakow.pl |
| Name | Affiliation | Role |
|---|---|---|
| Kazimierz PityĆski, Prof., Ph.D., M.D. | Jagiellonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian Univeristy | Recruiting | Krakow | Poland |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D011085 | Polycystic Ovary Syndrome |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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blood serum
| Resistin concentration in blood serum | Diagnostic Test | Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms |
|
| Omentin-1 concentration in blood serum | Diagnostic Test | Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms |
|
| 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 |