Insulin Action During Pregnancy in Woman at High Risk for Gestational Diabetes (DRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687479
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : December 18, 2014
Baton Rouge Area Foundation
Information provided by (Responsible Party):
Karen Elkind-Hirsch, Woman's

Brief Summary:
The project objective is to validate a new indirect estimate of insulin status in both pregnant African-American women and Caucasian women in southern Louisiana who are at risk for gestational diabetes mellitus. There are racial differences in carbohydrate metabolism that are potentially linked to complications during pregnancy and to increased risks of obesity and diabetes in later life. The investigators will explore the use of indexes of insulin status to identify the metabolic risk profile of pregnant women which may vary by race. Understanding whether there are differences which vary by race may influence clinical screening and treatment of pregnant women.

Condition or disease
Gestational Diabetes Mellitus

Detailed Description:
The major goal of our proposed study is to validate a new approach to estimating insulin sensitivity and ß-cell function in African-American women compared to non-Hispanic white women in southern Louisiana who are at a high risk for gestational diabetes mellitus (GDM). We will determine whether the whole body insulin sensitivity index (WBISI) and insulinogenic index (IGI) [derived from an oral glucose tolerance test (OGTT)] can be used during 24-28 weeks of pregnancy to accurately estimate the degree of insulin resistance relative to ß-cell function in women with GDM in those with impaired glucose tolerance (IGT) as well as those who are glucose tolerant. Fasting values will also be assessed using the homeostasis model assessment (HOMA-IR and HOMA-%B) to evaluate insulin resistance and ß-cell function. We will explore the potential use of these measures to define the metabolic risk profile of these pregnant women and compare them with obstetric outcomes. We will determine if there are differences in risk that vary by race. Second, given the high likelihood that women who manifest GDM will develop type 2 diabetes mellitus (DM), identification of these patients by ethnic group or other independent determinants will permit intervention after delivery that might delay or prevent the onset of type 2 DM.

Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinically Useful Methods for Assessment of Insulin Sensitivity and Beta Cell Function in Women at High Risk for Gestational Diabetes: Does Race Matter?
Study Start Date : January 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

normal glucose tolerance
Gestational Diabetes mellitus
Gestational Impaired glucose tolerance

Primary Outcome Measures :
  1. Insulin action measures [ Time Frame: 20-30 weeks of pregnancy ]

Secondary Outcome Measures :
  1. infant gestational age [ Time Frame: time of delivery ]

Biospecimen Retention:   Samples Without DNA
Blood samples for insulin measurements

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy, nondiabetic pregnant African-American and Caucasian women who have been scheduled for a standard 3-hour glucose tolerance test at 24-28 weeks in the Woman's Hospital Pathology laboratory.

Inclusion Criteria:

  • 18-42 years of age
  • at 20-30 weeks of gestation
  • Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism.

Exclusion Criteria:

  • <18 years or >42 years of age
  • non-Caucasian or non-African-American ethnicity
  • use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00687479

United States, Louisiana
Woman's Hospital Pathology Laboratory
Baton Rouge, Louisiana, United States, 70815
Sponsors and Collaborators
Baton Rouge Area Foundation
Principal Investigator: Karen E Elkind-Hirsch, Ph.D. Woman's Health Research Institute
Principal Investigator: Beverly Ogden, MD Woman's Pathology Laboratory

Responsible Party: Karen Elkind-Hirsch, Director of Research, Woman's Identifier: NCT00687479     History of Changes
Other Study ID Numbers: 05-013
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Karen Elkind-Hirsch, Woman's:
insulin sensitivity
insulin secretion
infant outcome

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs