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临床试验/NCT01838122
NCT01838122Unknown不适用

Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study

Southern Cross Fertility Centre1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Prevalence of HbA1C in both arms of the cohort of subjects

研究概览

简要总结

Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.

详细描述

In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS.

Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests.

Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.

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
15 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI of 25-35 Kg/Mt2
  • Atleast three of the Rotterdam criteria for diagnosis of PCOS.
  • Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder.

排除标准

  • Subjects with documented diagnosis of Metabolic Syndrome.
  • Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia.
  • 4.Subjects with basal FSH >/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.

结局指标

主要结局

Prevalence of HbA1C in both arms of the cohort of subjects

时间窗: September 2013

HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS

次要结局

未报告次要终点

研究者

发起方
Southern Cross Fertility Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

M.R. Bharucha

Faram E.Irani

Southern Cross Fertility Centre

研究点 (1)

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