Prevalence of HbA1C in Women With PCOS (WHI)

April 18, 2013 updated by: M.R. Bharucha, Southern Cross Fertility Centre

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

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400025
        • Southern Cross Fertility Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This population will have subjects with diagnosis of PCOS,by Rotterdam criteria regardless of complain(s)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
September 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

April 23, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HbA1C-PCOS
  • PCOS-IR (Registry Identifier: ICMJE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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