Polycystic Ovary SyndromeNCT01475565
Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Insulin Resistance, run by Virginia Commonwealth University at 1 site in United States.
Trial 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 unknown if there are factors that may predict which women are more at risk. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance, Insulin Sensitivity
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will be recruited from clinics in/near Richmond, VA.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-5051
About this study
Official title: 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.
Read the 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.
- Keywords
- polycystic ovary syndrome (PCOS), insulin sensitivity, insulin resistance, gestational diabetes, pregnancy, estrogen, glucose intolerance, obesity, ovulatory disorder, racial differences, hyperandrogenism
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Obesity, Diabetes, Gestational, Glucose Intolerance, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| African-American women | Observational study--no intervention | |
| Caucasian women | Observational study--no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Gestation Week 12-14 in Estrogen Metabolites at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Insulin Sensitivity at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Secondary outcomes (10)
Change from Gestation Week 12-14 in Fasting Insulin at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Fasting Glucose at Gestation Week 32-34
Measured: 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
Measured: 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
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation 12-14 in Matsuda Insulin Sensitivity Index at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Insulin Secretory Response at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Macronutrients at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Urinary Estrogen Metabolites at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Body Weight at Gestation Week 32-34
Measured: Gestation weeks 12-14, 24-26, and 32-34
Change from Gestation Week 12-14 in Physical Activity at Gestation Week 32-34
Measured: Gestational week 12-14, 24-26, 32-34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Only 2 participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Kai Cheang, Pharm. D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475565
- Sponsor's protocol ID
- HM13733
- Status last verified
- Dec 2015
- First submitted
- 8 Nov 2011
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance Before and During Pregnancy in Women With PCOS
- ClinicalTrials.gov ID
- NCT01475565
- Acronym / sponsor ID
- HM13733
- Keywords
- polycystic ovary syndrome (PCOS), insulin sensitivity, insulin resistance, gestational diabetes, pregnancy, estrogen, glucose intolerance, obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only 2 participants were enrolled
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African-American women | – | –Observational study--no intervention |
| Caucasian women | – | –Observational study--no intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from clinics in/near Richmond, VA.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
10 secondary outcomes
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
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
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
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
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
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
Change from Gestation Week 12-14 in Macronutrients at Gestation Week 32-34
Time frame: 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
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
Change from Gestation Week 12-14 in Physical Activity at Gestation Week 32-34
Time frame: Gestational week 12-14, 24-26, 32-34
Results and safety
The study was stopped early (reason given: Only 2 participants were enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Cheang, Pharm. D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Insulin Resistance, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 2 participants were enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.