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临床试验/NCT06793072
NCT06793072招募中不适用

Assessment of Adipokine Concentrations 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 300 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
300
试验地点
1
主要终点
Comparison of resistin concentration in three study groups

研究概览

简要总结

The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

详细描述

Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy among reproductive-age women, characterized primarily by insulin resistance (IR), which has a prevalence of 35% to 80%. Metabolic disturbances associated with PCOS contribute to a higher incidence of cardiovascular diseases and endometrial cancer prior to menopause. The hyperinsulinemic-euglycemic clamp study is regarded as the gold standard for assessing insulin sensitivity; however, its clinical application is limited. Alternative assessments, such as the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin or glucose tolerance tests, provide limited clinical utility. Therefore, there is a pressing need for the identification of more precise and universal markers of insulin resistance. There is a need to elucidate the precise role of adipokines in the etiology of PCOS and their association with insulin resistance, which is responsible for the development of adverse health-related complications.

The aim of the study is to measure and compare the concentrations of selected adipokines: leptin, resistin, omentin-1 across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

The tests will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer.

The concentrations of the investigated substances will be measured and compared within the three research groups.

Statistical analysis 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

  • Age 18-45

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(Edited)Restore original

研究组 & 干预措施

PCOS + no IR

Polycystic ovary syndrome + no insulin resistance

干预措施: Leptin concentration in blood serum (Diagnostic Test)

PCOS+IR

Polycystic ovary syndrome + insulin resistance

干预措施: Leptin concentration in blood serum (Diagnostic Test)

PCOS+IR

Polycystic ovary syndrome + insulin resistance

干预措施: Resistin concentration in blood serum (Diagnostic Test)

PCOS+IR

Polycystic ovary syndrome + insulin resistance

干预措施: Omentin-1 concentration in blood serum (Diagnostic Test)

PCOS + no IR

Polycystic ovary syndrome + no insulin resistance

干预措施: Resistin concentration in blood serum (Diagnostic Test)

PCOS + no IR

Polycystic ovary syndrome + no insulin resistance

干预措施: Omentin-1 concentration in blood serum (Diagnostic Test)

No PCOS

Women without PCOS (control)

干预措施: Leptin concentration in blood serum (Diagnostic Test)

No PCOS

Women without PCOS (control)

干预措施: Resistin concentration in blood serum (Diagnostic Test)

No PCOS

Women without PCOS (control)

干预措施: Omentin-1 concentration in blood serum (Diagnostic Test)

结局指标

主要结局

Comparison of resistin concentration in three study groups

时间窗: up to 6 months

Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups

Comparison of leptin concentration three study groups

时间窗: up to 6 months

Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups

Comparison of omentin-1 concentration in three study groups

时间窗: up to 6 months

Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study 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)

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