Clusterin Level Determination and Its Association With Metabolic Syndrome in Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- CLusterin level
研究概览
简要总结
Clusterin, a protein involved in metabolic syndrome, insulin resistance, and metabolic disorders associated with inflammation and oxidative stress such as atherosclerosis, Alzheimer's and some malignancies, has elevated levels in metabolic syndrome, PCOS, and the combination of these two groups. Clusterin could be used as an inflammatory marker to predict PCOS and metabolic syndrome.
详细描述
The study included 118 women diagnosed with PCOS according to the Rotterdam criteria and 62 age-matched healthy women without cardiovascular risk factors. The patients diagnosed with PCOS were also classified into phenotypes. No interventional examination was requested for patients A, B, C, and D, except for hormonal tests and blood collection for Human Clusterin. The demographic and clinical characteristics of all patients were compared, with the primary outcome being blood Clusterin levels. The secondary outcomes are blood Clusterin levels in women with and without metabolic syndrome in addition to PCOS, the relationship between PCOS phenotypes and Clusterin levels, and the relationship between Clusterin levels and clinical and laboratory parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 18 and 45,
- •natural bilateral ovaries and no functional cysts on transvaginal ultrasound.
排除标准
- •who have hyperandrogenism/hyperandrogenemia
- •who have non-classical congenital adrenal hyperplasia (17 OHP value >2 nmol/L)
- •who have thyroid disease (TSH >5 mlU/L),
- •women with hyperprolactinemia (Prolactin>30 mlU/mL)
- •patients taking hormonal drugs or ovulation induction agents.
结局指标
主要结局
CLusterin level
时间窗: 7 months
primary outcome is the measurement of blood Clusterin (Apolipoprotein J) levels in healthy women with and without PCOS
次要结局
未报告次要终点
研究者
Nefise Nazlı YENIGUL
Ph.D. Assistant Professor Department of Obstetrics and Gynecology
Sanliurfa Mehmet Akif Inan Education and Research Hospital