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临床试验/NCT07480993
NCT07480993已完成不适用

Evaluation of Serum Betatrophin Levels in Normal-Weight and Overweight Adolescents With Polycystic Ovary Syndrome

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Serum betatrophin levels

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in adolescents and women of reproductive age and is frequently associated with insulin resistance and an increased risk of metabolic complications. The mechanisms underlying these metabolic abnormalities are not fully understood. Betatrophin (angiopoietin-like protein 8, ANGPTL8) is a liver- and adipose tissue-derived protein involved in lipid and glucose metabolism and has been suggested to be associated with insulin resistance and metabolic stress. This study aims to evaluate serum betatrophin levels in adolescents with PCOS compared with age-matched healthy controls. Adolescents with PCOS will also be categorized according to body mass index (BMI) as normal-weight or overweight to investigate the potential influence of body weight. Additionally, the relationships between betatrophin levels and anthropometric parameters, hormonal profiles, and markers of insulin resistance will be examined.

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
16 Years 至 23 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Adolescent females aged 16-23 years
  • Post-menarche status
  • Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria (for Groups I and II)
  • Age-matched healthy females without PCOS for control group (Group III).
  • Ability and willingness to provide informed consent/assent
  • Willingness to comply with study procedures and blood sample collection

排除标准

  • Cardiovascular diseases including hypertension
  • Type 1 or type 2 diabetes mellitus
  • Morbid obesity
  • Primary adrenal insufficiency
  • Uterine fibroids
  • Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
  • Hepatic dysfunctions
  • Renal insufficiency
  • Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
  • Neurologic diseases
  • Psychiatric disorders
  • Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
  • History of any malignancy
  • History of exposure to chemotherapeutic agents or radiotherapy

研究组 & 干预措施

Overweight PCOS (Group I)

Adolescent females diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria, with a body mass index (BMI) ≥25 kg/m². Participants have not received prior medical or surgical treatment for PCOS and do not have chronic diseases such as diabetes, cardiovascular, thyroid, or rheumatologic disorders.

干预措施: Serum betatrophin levels (Other)

Normal-weight PCOS (Group II)

Adolescent females diagnosed with PCOS according to the Rotterdam criteria, with a BMI <25 kg/m². Participants have not received prior medical or surgical treatment for PCOS and do not have chronic diseases including diabetes, cardiovascular, thyroid, or rheumatologic disorders.

干预措施: Serum betatrophin levels (Other)

Healthy Controls (Group III)

Age-matched adolescent females without PCOS or any chronic endocrine, metabolic, or systemic diseases. Participants have not received prior medical or surgical treatment affecting metabolic or hormonal status.

干预措施: Serum betatrophin levels (Other)

结局指标

主要结局

Serum betatrophin levels

时间窗: Single measurement at baseline

picogram/milliliter

次要结局

  • Body mass index(Single measurement at baseline)
  • Homeostatic Model Assessment for Insulin Resistance(Single measurement at baseline)
  • Fasting glucose(Single measurement at baseline)
  • Fasting insulin(Single measurement at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Didem Eşkin Tanrıverdi

Medical Doctor

Ankara City Hospital Bilkent

研究点 (1)

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