Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorIstinye University

About this trial

Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a common endocrine and metabolic disorder associated with insulin resistance, hyperandrogenism, and an increased risk of long-term metabolic complications. Fetuin-A and resistin are adipokines implicated in insulin resistance and chronic inflammation and may serve as potential biomarkers for metabolic dysfunction in women with PMOS.

This prospective observational case-control study aims to compare serum and salivary Fetuin-A and resistin levels between women with PMOS and healthy controls. The study will evaluate the correlation between serum and salivary biomarker concentrations and investigate their associations with insulin resistance, lipid profile, and hormonal parameters. The findings may help determine whether salivary measurements can serve as reliable non-invasive biomarkers for the diagnosis and metabolic assessment of PMOS.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female, aged 18-35 years

Diagnosis of Polyendocrine Metabolic Ovarian Syndrome (PMOS) according to the Rotterdam criteria

BMI <30 kg/m²

Written informed consent

Disqualifiers

Pregnancy or breastfeeding

Diabetes mellitus

Chronic kidney or liver disease

Thyroid dysfunction

Trial population

Women aged 18-35 years with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and age-matched healthy women recruited from the outpatient gynecology and endocrinology clinics of Istinye University. Participants will undergo clinical evaluation and fasting blood and unstimulated saliva collection for biochemical analyses.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Blood and Saliva Biomarker Assessment

    Diagnostic test

    Participants will provide fasting venous blood and unstimulated saliva samples for measurement of Fetuin-A and resistin concentrations using enzyme-linked immunosorbent assay (ELISA). Metabolic and hormonal parameters, including fasting glucose, fasting insulin, HbA1c, lipid profile, total testosterone, sex hormone-binding globulin (SHBG), and dehydroepiandrosterone sulfate (DHEAS), will also be assessed. No therapeutic intervention will be administered.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: PMOS Group1 intervention
Group B: Healthy Control Group1 intervention

Trial outcomes

Primary outcomes

1

Correlation Between Serum and Salivary Fetuin-A and Resistin Levels

To determine the correlation between serum and salivary Fetuin-A and resistin concentrations in women with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and healthy controls.

Time frame
At baseline (Day 1)

Secondary outcomes

1

Serum Fetuin-A Levels

Comparison of serum Fetuin-A concentrations between women with PMOS and healthy controls.

Time frame
Baseline
2

Salivary Fetuin-A Levels

Comparison of salivary Fetuin-A concentrations between women with PMOS and healthy controls

Time frame
Baseline
3

Serum Resistin Levels

Comparison of serum resistin concentrations between women with PMOS and healthy controls.

Time frame
Baseline
4

Salivary Resistin Levels

Comparison of salivary resistin concentrations between women with PMOS and healthy controls.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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