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临床试验/NCT06793098
NCT06793098招募中不适用

Assessment of the Concentrations of Functional Proteins as Potential Early Markers of Insulin Resistance in Women With Polycystic Ovary Syndrome

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
Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups

研究概览

简要总结

The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.

详细描述

Polycystic Ovary Syndrome (PCOS) is currently the most common endocrine disorder in women of reproductive age with an unknown etiology. A predominant metabolic feature of PCOS is insulin resistance (IR), which contributes to the pathogenesis and expression of other symptoms of the syndrome, such as hyperandrogenism. The metabolic disturbances in women with PCOS result in a higher incidence of cardiovascular diseases and endometrial cancer in the premenopausal age. The gold standard for assessing peripheral tissue sensitivity to insulin is the hyperinsulinemic-euglycemic clamp technique; however, this method is not commonly used in clinical practice due to its complexities. Instead, simpler tests, such as the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin measurements along with glucose tolerance tests, are employed. These methods are utilized for diagnosing insulin resistance rather than identifying predispositions. Therefore, there is an urgent need to identify more precise markers of IR that could be used in routine early-stage assessments. Given the long-term complications associated with PCOS, which can shorten life expectancy, early diagnosis and treatment of IR are crucial. Furthermore, such studies may contribute to exploring the etiopathogenesis of the syndrome. The discovery of "markers" that can predict or diagnose metabolic abnormalities at an early stage, prior to the onset of clinical symptoms, would facilitate early intervention and treatment, thus preventing a decline in quality of life associated with PCOS.

This study will measure and compare the concentrations of locally acting hormones: ghrelin, kisspeptin, and zonulin in three research groups: women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), women with PCOS without IR, and women without PCOS. Measurements will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. Statistical calculations will be conducted 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

  • 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

Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)

干预措施: Measurement of kisspeptin concentration (Diagnostic Test)

Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)

干预措施: Measurement of ghrelin concentration (Diagnostic Test)

Women with polycystic ovary syndrome (PCOS) and insulin resistance (IR)

干预措施: Measurement of zonulin concentration (Diagnostic Test)

Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)

干预措施: Measurement of kisspeptin concentration (Diagnostic Test)

Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)

干预措施: Measurement of ghrelin concentration (Diagnostic Test)

Women with polycystic ovary syndrome (PCOS) without insulin resistance (IR)

干预措施: Measurement of zonulin concentration (Diagnostic Test)

Women without PCOS

干预措施: Measurement of kisspeptin concentration (Diagnostic Test)

Women without PCOS

干预措施: Measurement of ghrelin concentration (Diagnostic Test)

Women without PCOS

干预措施: Measurement of zonulin concentration (Diagnostic Test)

结局指标

主要结局

Measurement and comparison of kisspeptin concentrations expressed in [pg/ml] in all three study groups

时间窗: up to 6 months

Measurement and comparison of ghrelin concentrations expressed in [pg/ml] in all three study groups

时间窗: up to 6 months

Measurement and comparison of zonulin concentrations expressed in [pg/ml] in all three study groups

时间窗: up to 6 moths

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)

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