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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Polycystic Ovary Syndrome Insulin Resistance Insulin Sensitivity Obesity Pregnancy

Keywords

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polycystic ovary syndrome (PCOS) insulin sensitivity insulin resistance gestational diabetes pregnancy estrogen glucose intolerance obesity ovulatory disorder racial differences hyperandrogenism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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African-American women

Observational study--no intervention

No interventions assigned to this group

Caucasian women

Observational study--no intervention

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kai Cheang, Pharm. D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM13733

Identifier Type: -

Identifier Source: org_study_id