Prevalence of HbA1C in Women With PCOS

• Conditions: Polycystic Ovarian Syndrome; Pelvic Endometriosis; Insulin Resistance; Non-insulin Dependent Diabetes Mellitus; Tubal Obstruction

• Registration Number: NCT01838122
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23
• Primary Completion: 2013-09
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of HbA1C in both arms of the cohort of subjects	September 2013	HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS

Trial Locations

Locations (1)

Southern Cross Fertility Centre; 🇮🇳 Mumbai, Maharashtra, India