Study of Scube-1 and Scube-3 in Polycystic Ovary Syndrome (PCOS) and Their Possible Use as Inflammatory Markers and as a Link Between PCOS and Cardiovascular Events.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Circulating SCUBE-1 levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •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
排除标准
- •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
- •Refusal to sign informed consent
研究组 & 干预措施
Arm 1: PCOS - Normoinsulinemic
Description: Women with PCOS and normal insulin sensitivity Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA
干预措施: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement (Diagnostic Test)
Arm 2: PCOS - Hyperinsulinemic
Description: Women with PCOS and insulin resistance Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA
干预措施: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement (Diagnostic Test)
Arm 3: Healthy Controls
Description: Healthy women of reproductive age without PCOS Intervention: Blood sample collection for SCUBE-1 and SCUBE-3 measurement by ELISA
干预措施: Blood Sample Collection for SCUBE-1 and SCUBE-3 Measurement (Diagnostic Test)
结局指标
主要结局
Circulating SCUBE-1 levels
时间窗: At enrollment
Comparison of SCUBE-1 plasma concentrations among normoinsulinemic PCOS, hyperinsulinemic PCOS, and healthy controls
次要结局
- Circulating SCUBE-3 levels(At enrollment)
- Correlation with clinical and laboratory parameters(At enrollment)