Evaluation of the Activity of Chronic Inflammation and Its Impact on Metabolic and Hormonal Parameters in Various PCOS Phenotypes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes
研究概览
简要总结
Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.
详细描述
The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •age 18-45 years
- •PCOS syndrome confirmed by the Rotterdam criteria
排除标准
- •absence of at least one ovary
- •diagnosed and/or treated other metabolic disease
- •diagnosed and/or treated other endocrine disease
结局指标
主要结局
Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes
时间窗: up to 3 months
Measurement and comparison of concentrations of IL-1 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes
时间窗: up to 3 months
Measurement and comparison of concentrations of IL-10 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes
时间窗: up to 3 months
Measurement and comparison of concentrations of TNF-alpha (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes
时间窗: up to 3 months
Measurement and comparison of leukocyte count (n/µL) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes
时间窗: up to 3 months
Measurement and comparison of concentrations of IL-6 (pg/ml) in peripheral blood in the four PCOS phenotypes
Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes
时间窗: up to 3 months
Measurement and comparison of concentrations of CRP (mg/l) in peripheral blood in the four PCOS phenotypes
次要结局
- Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes(up to 3 months)
- Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes(up to 3 months)
研究者
Iwona Magdalena Gawron
Principal Investigator
Jagiellonian University