Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome
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Purpose
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.
| Condition |
|---|
|
Polycystic Ovary Syndrome Insulin Resistance Insulin Sensitivity Obesity Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Insulin Resistance Before and During Pregnancy in Women With PCOS |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Change from Gestation Week 12-14 in Macronutrients at Gestation Week 32-34 [ Time Frame: Gestation weeks 12-14, 24-26, and 32-34 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change from Gestation Week 12-14 in Physical Activity at Gestation Week 32-34 [ Time Frame: Gestational week 12-14, 24-26, 32-34 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
- blood sample
- blood sample sample for DNA
- fasting plasma for insulin, glucose, sex steroids (testosterone, androstenedione, DHEA-sulfate, estradiol, estrone, progesterone), sex hormone-binding globulin and estrogen metabolites
- blood sample for oral glucose tolerance test
- urine for estrogen metabolites
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| African-American women |
| Caucasian women |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants will be recruited from clinics in/near Richmond, VA.
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.
Contacts and Locations| Contact: Kai Cheang, Pharm. D. | 804-828-9698 | KICHEANG@VCU.EDU |
| United States, Virginia | |
| Virginia Commonwealth University Medical Center | Recruiting |
| Richmond, Virginia, United States, 23298-5051 | |
| Principal Investigator: | Kai Cheang, Pharm. D. | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01475565 History of Changes |
| Other Study ID Numbers: | HM13733 |
| Study First Received: | November 8, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
pregnancy polycystic ovary syndrome (PCOS) insulin sensitivity insulin resistance gestational diabetes estrogen |
glucose intolerance obesity ovulatory disorder racial differences hyperandrogenism |
Additional relevant MeSH terms:
|
Insulin Resistance Obesity Polycystic Ovary Syndrome Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Ovarian Cysts |
Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013