Jagiellonian Univeristy
Krakow, Poland
Location status: Recruiting
NCT Number: NCT06793072
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Krakow, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms
Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms
Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms
Time frame: up to 6 months
Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups
Time frame: up to 6 months
Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups
Time frame: up to 6 months
Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study groups
Contact information is provided by the study sponsor or research team.
Iwona Gawron, Ph.D., M.D.
CONTACT
Robert Jach, Prof., Ph.D., M.D.
CONTACT
Jagiellonian University
Other
Assessment of Adipokine Concentrations and Their Association With the Metabolic Profile of Women With PCOS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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