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Insulin Resistance Before and During Pregnancy in Women With PCOS

18 Years
40 Years
Open (Enrolling)
Polycystic Ovary Syndrome, Insulin Resistance, Insulin Sensitivity, Obesity, Pregnancy

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Trial Information

Insulin Resistance Before and During Pregnancy in Women With PCOS

The polycystic ovary syndrome is the leading cause of female infertility in the United
States. The disorder affects approximately 6-10% of women of reproductive age. Insulin is
a hormone that helps the body to take up sugar from the bloodstream. It is widely accepted
that "insulin resistance" may be responsible for the polycystic ovary syndrome. Women are
insulin resistant when their bodies do not respond to insulin's action to handle sugar as
they normally should. Because of this insulin resistance, when women with the polycystic
ovary syndrome become pregnant, they are at a higher risk of developing gestational
diabetes. Gestational diabetes carries risk to both the mother and the baby. The purpose of
this study is to determine whether certain factors in women with the polycystic ovary
syndrome are linked to risk of gestational diabetes. We propose to look at demographic
factors, as well as the body's handling of estrogen (a female hormone present in high
quantities during pregnancy) in this study.

Inclusion Criteria:

- Diagnosis of PCOS prior to pregnancy

- 18-40 years of age

- Documented BMI 30-40 kg/m2 (within 3 months prior to pregnancy or within 8 weeks of

- Either of Caucasian or African-American decent by self report.

- Pregnant or attempting pregnancy

Exclusion Criteria:

- Preexisting Diabetes (impaired glucose tolerance will not be an exclusion criterion
because of the high prevalence of impaired glucose tolerance in the PCOS population).

- Hemoglobin < 8 or hemoglobin <10 with symptoms of anemia.

- Use of tobacco, alcohol or illicit substances.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change from Gestation Week 12-14 in Estrogen Metabolites at Gestation Week 32-34

Outcome Time Frame:

Gestation weeks 12-14, 24-26, and 32-34

Safety Issue:


Principal Investigator

Kai Cheang, Pharm. D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

August 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin Resistance
  • Insulin Sensitivity
  • Obesity
  • Pregnancy
  • polycystic ovary syndrome (PCOS)
  • insulin sensitivity
  • insulin resistance
  • gestational diabetes
  • pregnancy
  • estrogen
  • glucose intolerance
  • obesity
  • ovulatory disorder
  • racial differences
  • hyperandrogenism
  • Insulin Resistance
  • Obesity
  • Polycystic Ovary Syndrome



Virginia Commonwealth University Medical CenterRichmond, Virginia  23298