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SCUBE Proteins in Polycystic Ovary Syndrome (IPSOS)

ConditionsPolycystic Ovary Syndrome (PCOS)Insulin Resistance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

History of cardiovascular disease

Diabetes mellitus or impaired glucose tolerance

Hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement

    Diagnostic test

    Blood sample collection performed specifically for research purposes to measure circulating SCUBE-1 and SCUBE-3 levels using enzyme-linked immunosorbent assay (ELISA).

Treatment groups

56 Participants
are divided into 3 treatment groups
Group A: Arm 1: PCOS - NormoinsulinemicExperimental treatment 1 intervention
Group B: Arm 2: PCOS - HyperinsulinemicExperimental treatment 1 intervention
Group C: Arm 3: Healthy ControlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Circulating SCUBE-1 levels

Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls

Time frame
At enrollment

Secondary outcomes

1

Circulating SCUBE-3 levels

Comparison of SCUBE-3 plasma concentrations among study groups

Time frame
At enrollment
2

Correlation with clinical and laboratory parameters

Association between SCUBE-1 and SCUBE-3 levels and clinical (age, BMI, hirsutism, acne, menstrual irregularities) and laboratory variables (lipid profile, androgen levels)

Time frame
At enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: