Status:
TERMINATED
Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Polycystic Ovary Syndrome
Insulin Resistance
Eligibility:
FEMALE
18-40 years
Brief Summary
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 un...
Detailed 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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01475565
Start Date
May 1 2013
End Date
August 1 2014
Last Update
December 14 2015
Active Locations (1)
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1
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-5051