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Clinical Trials/NCT01838122
NCT01838122UnknownNot Applicable

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

Southern Cross Fertility Centre1 site in 1 country300 target enrollmentStarted: April 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
300
Locations
1
Primary Endpoint
Prevalence of HbA1C in both arms of the cohort of subjects
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to 40 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Prevalence of HbA1C in both arms of the cohort of subjects

Time Frame: September 2013

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Southern Cross Fertility Centre
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

M.R. Bharucha

Faram E.Irani

Southern Cross Fertility Centre

Study Sites (1)

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