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Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Terminated

Conditions

Insulin Resistance
Polycystic Ovary Syndrome
Obesity
Insulin Sensitivity
Pregnancy

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT01475565
HM13733

Details and patient eligibility

About

The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy complications. It is unknown if there are factors that may predict which women are more at risk.

The goal of this study is to evaluate the risk factors of gestational diabetes, such as dietary and physical activity factors, race, and how the body handles its own hormones during pregnancy. Our long term goal is to contribute in finding ways to successfully prevent gestational diabetes.

Full description

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.

Enrollment

2 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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 gestation)
  • 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.

Trial design

2 participants in 2 patient groups

African-American women
Description:
Observational study--no intervention
Caucasian women
Description:
Observational study--no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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