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

This study has been completed.
Sponsor:
Collaborator:
Baton Rouge Area Foundation
Information provided by (Responsible Party):
Karen Elkind-Hirsch, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier:
NCT00687479
First received: May 28, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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
Gestational Diabetes Mellitus

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by BC Women's Hospital & Health Centre:

Primary Outcome Measures:
  • Insulin action measures [ Time Frame: 20-30 weeks of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • infant gestational age [ Time Frame: time of delivery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples for insulin measurements


Enrollment: 175
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1-NGT
normal glucose tolerance
2-GDM
Gestational Diabetes mellitus
3.GIGT
Gestational Impaired glucose tolerance

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders 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.

Criteria

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
  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: NCT00687479

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

Publications:
Responsible Party: Karen Elkind-Hirsch, Director of Research, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier: NCT00687479     History of Changes
Other Study ID Numbers: 05-013
Study First Received: May 28, 2008
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by BC Women's Hospital & Health Centre:
insulin sensitivity
insulin secretion
infant outcome

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

ClinicalTrials.gov processed this record on September 22, 2014