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

15 Years
40 Years
Open (Enrolling)
Polycystic Ovarian Syndrome, Pelvic Endometriosis, Insulin Resistance, Non-insulin Dependent Diabetes Mellitus, Tubal Obstruction

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence of HbA1C in both arms of the cohort of subjects

Outcome Description:

HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS

Outcome Time Frame:

September 2013

Safety Issue:


Principal Investigator

Manchi R Bharucha, Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Southern Cross Fertility Centre


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

November 2013

Related Keywords:

  • Polycystic Ovarian Syndrome
  • Pelvic Endometriosis
  • Insulin Resistance
  • Non-insulin Dependent Diabetes Mellitus
  • Tubal Obstruction
  • PCOS
  • HbA1C
  • Insulin resistance
  • OGTT
  • HOMA-B-cell
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Endometriosis
  • Insulin Resistance
  • Polycystic Ovary Syndrome
  • Fallopian Tube Diseases