Insulin Resistance, Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
SCUBE-1, SCUBE-3, Polycystic Ovary Syndrome, PCOS, Insulin Resistance, Inflammation, Cardiovascular Risk
Brief summary
This study investigates circulating levels of SCUBE-1 and SCUBE-3 proteins in women with polycystic ovary syndrome (PCOS) compared with healthy controls. Differences between normoinsulinemic and hyperinsulinemic PCOS subgroups will be evaluated, as well as correlations with clinical and metabolic parameters related to inflammation and cardiovascular risk.
Detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and is frequently associated with insulin resistance, chronic low-grade inflammation, and increased cardiovascular risk. SCUBE proteins (Signal peptide-CUB-EGF domain-containing proteins) are recently identified molecules involved in inflammation, angiogenesis, and platelet activation. Their role in PCOS has not been fully elucidated. This interventional, non-randomized study will measure circulating SCUBE-1 and SCUBE-3 levels in women with PCOS and healthy controls. PCOS patients will be stratified into normoinsulinemic and hyperinsulinemic subgroups based on previously performed metabolic assessments. Blood samples will be collected during routine clinical practice and analyzed using ELISA assays. The study aims to assess SCUBE proteins as potential biomarkers of inflammation and cardiovascular risk in PCOS.
Interventions
DIAGNOSTIC_TESTBlood Sample Collection for SCUBE-1 and SCUBE-3 Measurement
Blood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects aged 18-35 years * Diagnosis of polycystic ovary syndrome (normoinsulinemic or hyperinsulinemic) * Availability of basal hormonal evaluation and oral glucose tolerance test * Healthy women for control group * Written informed consent
Exclusion criteria
* Pregnancy * History of cardiovascular disease * Diabetes mellitus or impaired glucose tolerance * Hypertension * Significant hepatic or renal disease * Other endocrine disorders * Neoplastic diseases * Psychiatric disorders * Autoimmune diseases * Shift work * Obesity * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circulating SCUBE-1 levels | At enrollment | Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating SCUBE-3 levels | At enrollment | Comparison of SCUBE-3 plasma concentrations among study groups |
| Correlation with clinical and laboratory parameters | At enrollment | Association between SCUBE-1 and SCUBE-3 levels and clinical (age, BMI, hirsutism, acne, menstrual irregularities) and laboratory variables (lipid profile, androgen levels) |
Countries
Italy
Contacts
CONTACTRosanna Apa, MD, PhD
CONTACTAnna Tropea, MD, PhD
PRINCIPAL_INVESTIGATORRosanna Apa, MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed