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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01475565
First received: November 8, 2011
Last updated: May 24, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475565

Locations
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298-5051
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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: May 24, 2013
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
Syndrome
Adnexal Diseases
Body Weight
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Neoplasms
Nutrition Disorders
Ovarian Cysts
Ovarian Diseases
Overnutrition
Overweight
Pathologic Processes
Signs and Symptoms
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014