Correlation of Serum and Salivary Fetuin-A and Resistin Levels With Metabolic and Hormonal Parameters in Women With Polyendocrine Metabolic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Correlation Between Serum and Salivary Fetuin-A and Resistin Levels
研究概览
简要总结
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.
详细描述
Polyendocrine Metabolic Ovarian Syndrome (PMOS) is a complex endocrine disorder characterized by reproductive, metabolic, and hormonal abnormalities. Insulin resistance, chronic low-grade inflammation, and hyperandrogenism play central roles in its pathophysiology. Identifying reliable and non-invasive biomarkers may improve early diagnosis, metabolic risk assessment, and long-term clinical follow-up.
Fetuin-A is a glycoprotein involved in insulin signaling and glucose metabolism, whereas resistin is a pro-inflammatory adipokine associated with insulin resistance and metabolic dysfunction. Previous studies evaluating serum concentrations of these biomarkers in women with PMOS have reported inconsistent findings, and little is known about whether salivary concentrations accurately reflect serum levels.
This prospective observational case-control study will enroll 80 women aged 18-35 years, including 40 women diagnosed with PMOS according to the Rotterdam criteria and 40 age-matched healthy controls. Fasting blood and unstimulated saliva samples will be collected simultaneously. Serum and salivary Fetuin-A and resistin concentrations will be measured 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), dehydroepiandrosterone sulfate (DHEAS), and the free androgen index (FAI), will also be evaluated.
The primary objective is to determine the correlation between serum and salivary Fetuin-A and resistin levels. Secondary objectives include evaluating associations between these biomarkers and insulin resistance, lipid profile, anthropometric measurements, and hormonal parameters, as well as assessing the potential utility of salivary biomarkers as non-invasive tools for the metabolic evaluation of women with PMOS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •PMOS Group:
- •Female, aged 18-35 years
- •Diagnosis of Polyendocrine Metabolic Ovarian Syndrome (PMOS) according to the Rotterdam criteria
- •BMI <30 kg/m²
- •Written informed consent
- •Healthy Control Group:
- •Female, aged 18-35 years
- •Regular menstrual cycles
- •No diagnosis of PMOS
- •BMI <30 kg/m²
- •Written informed consent
排除标准
- •Pregnancy or breastfeeding
- •Diabetes mellitus
- •Chronic kidney or liver disease
- •Thyroid dysfunction
- •Hyperprolactinemia
- •Cushing syndrome
- •Non-classic congenital adrenal hyperplasia
- •Use of hormonal contraceptives, anti-androgens, glucocorticoids, metformin, or insulin-sensitizing medications within the previous 3 months
- •Severe periodontal disease or active oral infection
研究组 & 干预措施
PMOS Group
Women aged 18 to 35 years diagnosed with Polyendocrine Metabolic Ovarian Syndrome according to the Rotterdam criteria. Participants will undergo clinical and anthropometric evaluation, and fasting serum and unstimulated saliva samples will be collected for Fetuin-A, resistin, metabolic, and hormonal measurements.
干预措施: Blood and Saliva Biomarker Assessment (Diagnostic Test)
Healthy Control Group
Women aged 18 to 35 years with regular menstrual cycles and without Polyendocrine Metabolic Ovarian Syndrome. Participants will undergo the same clinical, anthropometric, serum, and saliva assessments as the PMOS group.
干预措施: Blood and Saliva Biomarker Assessment (Diagnostic Test)
结局指标
主要结局
Correlation Between Serum and Salivary Fetuin-A and Resistin Levels
时间窗: At baseline (Day 1)
To determine the correlation between serum and salivary Fetuin-A and resistin concentrations in women with Polyendocrine Metabolic Ovarian Syndrome (PMOS) and healthy controls.
次要结局
- Serum Fetuin-A Levels(Baseline)
- Salivary Fetuin-A Levels(Baseline)
- Serum Resistin Levels(Baseline)
- Salivary Resistin Levels(Baseline)
- Correlation Between Fetuin-A and Resistin Concentrations and HOMA-IR(Baseline)
- Correlation Between Fetuin-A and Resistin Concentrations and SHBG Concentration(Baseline)
- Correlation of Fetuin-A and Resistin Concentrations With DHEAS Concentration(Baseline)
- Correlation of Fetuin-A and Resistin Concentrations With Free Androgen Index(Baseline)
- Correlation of Fetuin-A and Resistin Concentrations With Total Cholesterol Concentration(Baseline)
- Correlation of Fetuin-A and Resistin Concentrations With LDL Cholesterol Concentration(Baseline)
- Correlation of Fetuin-A and Resistin Concentrations With HDL Cholesterol Concentration(Baseline)
- Correlation of Fetuin-A and Resistin Concentrations With Triglyceride Concentration(Baseline)
- Correlation Between Fetuin-A and Resistin Concentrations and Total Testosterone Concentration(Baseline)
- Correlation Between Fetuin-A and Resistin Concentrations and DHEAS Concentration(Baseline)
- Correlation Between Fetuin-A and Resistin Concentrations and Free Androgen Index(Baseline)