跳至主要内容
临床试验/NCT06793085
NCT06793085招募中不适用

Assessment of the Concentrations of Pro- and Anti-inflammatory Cytokines and Their Association With the Metabolic Profile of Women With PCOS

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Il-6 concentration

研究概览

简要总结

The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

详细描述

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy among women of reproductive age, which, in addition to menstrual disorders and infertility due to anovulation, is characterized by insulin resistance (IR). The metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The severity of IR in women with PCOS is linked to abdominal obesity. There is an urgent need to identify more precise and universal markers of insulin resistance than the HOMA-IR index or glucose tolerance tests, which are intended to identify existing disorders rather than predispositions. Additionally, there is a need to investigate the balance of pro-inflammatory and anti-inflammatory parameters in PCOS and their relationship with insulin resistance, which is responsible for the development of adverse health complications.

The objective of this study is to measure and compare the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, and the anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Tests will be conducted using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. The concentrations of the substances under investigation will be measured and compared among the three study groups. Statistical analysis will be performed using SPSS Statistics software.

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

入选标准

  • women aged 18-45 years

排除标准

  • previous removal of at least one ovary
  • treated diabetes of any type
  • diagnosed and treated metabolic diseases
  • diagnosed and treated autoimmune diseases
  • diagnosed and treated autoinflammatory diseases

研究组 & 干预措施

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

干预措施: Measurement of interleukin-18 (il-18) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

干预措施: Measurement of interleukin-4 (il-4) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

干预措施: Measurement of interleukin-6 (il-6) concentration in blood serum (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

干预措施: Measurement of fasting tumor necrosis factor α (TNF-α) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

干预措施: Measurement of interleukin-18 (il-18) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

干预措施: Measurement of interleukin-6 (il-6) concentration in blood serum (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ insulin resistance (IR)

干预措施: Measurement of fasting tumor necrosis factor α (TNF-α) concentration (Diagnostic Test)

Polycystic ovary syndrome (PCOS)+ no insulin resistance (IR)

干预措施: Measurement of interleukin-4 (il-4) concentration (Diagnostic Test)

No PCOS

干预措施: Measurement of interleukin-6 (il-6) concentration in blood serum (Diagnostic Test)

No PCOS

干预措施: Measurement of fasting tumor necrosis factor α (TNF-α) concentration (Diagnostic Test)

No PCOS

干预措施: Measurement of interleukin-18 (il-18) concentration (Diagnostic Test)

No PCOS

干预措施: Measurement of interleukin-4 (il-4) concentration (Diagnostic Test)

结局指标

主要结局

Il-6 concentration

时间窗: up to 6 months

Measurement and comparison of serum interleukin-6 (il-6) concentration expressed in \[pg/ml\] in three research groups

Il-18 concentration

时间窗: up to 6 months

Measurement and comparison of serum interleukin-18 (il-18) concentration expressed in \[pg/ml\] in three research groups

Il-4 concentration

时间窗: up to 6 months

Measurement and comparison of serum interleukin-4 (il-4) concentration expressed in \[pg/ml\] in three research groups

TNF-α concentration

时间窗: up to 6 months

Measurement and comparison of serum tumor necrosis factor α (TNF-α) concentration expressed in \[pg/ml\] in three research groups

次要结局

未报告次要终点

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iwona Magdalena Gawron

PhD, MD, Principal Investigator

Jagiellonian University

研究点 (1)

Loading locations...

相似试验