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Prevalence of HbA1C in Women With PCOS (WHI)

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ClinicalTrials.gov Identifier: NCT01838122
Recruitment Status : Unknown
Verified April 2013 by M.R. Bharucha, Southern Cross Fertility Centre.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
M.R. Bharucha, Southern Cross Fertility Centre

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.

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

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 Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study
Study Start Date : April 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Study Arm
This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria)
Control arm
This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
This population will have subjects with diagnosis of PCOS,by Rotterdam criteria regardless of complain(s)
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838122


Locations
India
Southern Cross Fertility Centre
Mumbai, Maharashtra, India, 400025
Sponsors and Collaborators
Southern Cross Fertility Centre
Investigators
Study Director: Manchi R Bharucha, Ph.D Southern Cross Fertility Centre
Study Director: Manchi R Bharucha, Ph.D. Souther Cross Fertility Centre

Publications of Results:
Responsible Party: M.R. Bharucha, Faram E.Irani, Southern Cross Fertility Centre
ClinicalTrials.gov Identifier: NCT01838122     History of Changes
Other Study ID Numbers: HbA1C-PCOS
PCOS-IR ( Registry Identifier: ICMJE )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by M.R. Bharucha, Southern Cross Fertility Centre:
PCOS
HbA1C
Insulin resistance
OGTT
HOMA-IR
HOMA-B-cell

Additional relevant MeSH terms:
Genital Diseases, Female
Diabetes Mellitus
Insulin Resistance
Endometriosis
Polycystic Ovary Syndrome
Diabetes Mellitus, Type 2
Fallopian Tube Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders