Prevalence of HbA1C in Women With PCOS

NCT ID: NCT01838122

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Polycystic Ovarian Syndrome Pelvic Endometriosis Insulin Resistance Non-insulin Dependent Diabetes Mellitus Tubal Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Arm

This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria)

No interventions assigned to this group

Control arm

This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subjects with documented diagnosis of Metabolic Syndrome.
2. 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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Southern Cross Fertility Centre

OTHER

Sponsor Role lead

Responsible Party

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M.R. Bharucha

Faram E.Irani

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manchi R Bharucha, Ph.D

Role: STUDY_DIRECTOR

Southern Cross Fertility Centre

Manchi R Bharucha, Ph.D.

Role: STUDY_DIRECTOR

Souther Cross Fertility Centre

Locations

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Southern Cross Fertility Centre

Mumbai, Maharashtra, India

Site Status

Countries

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India

References

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Kim JJ, Choi YM, Cho YM, Jung HS, Chae SJ, Hwang KR, Hwang SS, Ku SY, Kim SH, Kim JG, Moon SY. Prevalence of elevated glycated hemoglobin in women with polycystic ovary syndrome. Hum Reprod. 2012 May;27(5):1439-44. doi: 10.1093/humrep/des039. Epub 2012 Feb 21.

Reference Type RESULT
PMID: 22357766 (View on PubMed)

Other Identifiers

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PCOS-IR

Identifier Type: REGISTRY

Identifier Source: secondary_id

HbA1C-PCOS

Identifier Type: -

Identifier Source: org_study_id

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