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

Obesity Clinical Trial

Official title:

Insulin Resistance Before and During Pregnancy in Women With PCOS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01475565
• Other study ID #: HM13733
• Status: Terminated
• Phase: N/A
• First received: November 8, 2011
• Last updated: December 10, 2015
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Polycystic Ovary Syndrome
• Pregnancy

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Gestation Week 12-14 in Estrogen Metabolites at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	No
Primary	Change from Gestation Week 12-14 in Insulin Sensitivity at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation Week 12-14 in Fasting Insulin at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation Week 12-14 in Fasting Glucose at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation Week 12-14 in Areas-under-the-response-curve of Insulin at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation Week 12-14 in Areas-under-the-response-curve of Glucose at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation 12-14 in Matsuda Insulin Sensitivity Index at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation Week 12-14 in Insulin Secretory Response at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	Yes
Secondary	Change from Gestation Week 12-14 in Macronutrients at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	No
Secondary	Change from Gestation Week 12-14 in Urinary Estrogen Metabolites at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	No
Secondary	Change from Gestation Week 12-14 in Body Weight at Gestation Week 32-34		Gestation weeks 12-14, 24-26, and 32-34	No
Secondary	Change from Gestation Week 12-14 in Physical Activity at Gestation Week 32-34		Gestational week 12-14, 24-26, 32-34	No