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

December 10, 2015 updated by: Virginia Commonwealth University

Insulin Resistance Before and During Pregnancy in Women With PCOS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298-5051
        • Virginia Commonwealth University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from clinics in/near Richmond, VA.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
African-American women
Observational study--no intervention
Caucasian women
Observational study--no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Gestation Week 12-14 in Estrogen Metabolites at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Insulin Sensitivity at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Gestation Week 12-14 in Fasting Insulin at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Fasting Glucose at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Areas-under-the-response-curve of Insulin at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Areas-under-the-response-curve of Glucose at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation 12-14 in Matsuda Insulin Sensitivity Index at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Insulin Secretory Response at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Macronutrients at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Urinary Estrogen Metabolites at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Body Weight at Gestation Week 32-34
Time Frame: Gestation weeks 12-14, 24-26, and 32-34
Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Physical Activity at Gestation Week 32-34
Time Frame: Gestational week 12-14, 24-26, 32-34
Gestational week 12-14, 24-26, 32-34

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kai Cheang, Pharm. D., Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM13733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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