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NCT01838122 Clinical Trial

Prevalence of HbA1C in Women With PCOS

Insulin Resistance Clinical Trial

— WHI  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01838122
Other study ID # HbA1C-PCOS
Secondary ID PCOS-IR
Status Active, not recruiting
Phase N/A
First received April 15, 2013
Last updated April 18, 2013
Start date April 2013
Est. completion date November 2013

Study information
Verified date April 2013
Source Southern Cross Fertility Centre
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date November 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 40 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
India Southern Cross Fertility Centre Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Southern Cross Fertility Centre

Country where clinical trial is conducted

India, 

References & Publications (1)

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 Fe — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of HbA1C in both arms of the cohort of subjects HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS September 2013 No
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