跳至主要内容
临床试验/NCT02467751
NCT02467751Unknown不适用

Metabolic Profile in Women of Different Body Composition With Polycystic Ovary Syndrome

Irmandade da Santa Casa de Misericordia de Sao Paulo1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Metabolic profile

研究概览

简要总结

Metabolic profile in women of different body composition with polycystic ovary syndrome.

详细描述

Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. In both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. Exams will be requested: metabolic profile (total cholesterol (mg/dL) and fractions, triglycerides (mg/dL), blood count, liver function (U/L) and classical glycemic index (mg/dL); hormonal profile - insulin (uIU/ml), luteinizing hormone (IU/L), follicle stimulating hormone (IU/L), thyreostimulating hormone (uIU/ML), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). Body composition (BMI) will be performed by absorption technique of two low energy beams emitted by X-ray - full body densitometry (DEXA). Expected result: To evaluate visceral fat and truncal of patients with diagnosis of Polycystic Ovary Syndrome without obesity.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 39 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.

排除标准

  • Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL)
  • Cushing's syndrome
  • Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal
  • Antidiabetic and antiobesity drugs.

结局指标

主要结局

Metabolic profile

时间窗: 12 months

total cholesterol (mg/dL) and fractions, triglycerides (mg/dL) will estimate

次要结局

  • Classical glycemic index(12 months)
  • Total and free testosterone(12 months)
  • Follicle stimulating hormone(12 months)
  • 17-hydroxyprogesterone(12 months)
  • Liver function(12 months)
  • Hormonal profile - insulin(12 months)
  • Prolactin(12 months)
  • luteinizing hormone(12 months)
  • thyreostimulating hormone(12 months)
  • Dehydroepiandrosterone(12 months)
  • DEXA(12 months)

研究者

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

Carolina Furtado Macruz

Doctor

Irmandade da Santa Casa de Misericordia de Sao Paulo

研究点 (1)

Loading locations...

相似试验