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OpenTrials
Completed

NCT Number: NCT00687479

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Insulin action measures

    Time frame: 20-30 weeks of pregnancy

Secondary outcomes

  1. infant gestational age

    Time frame: time of delivery

Sponsors and collaborators

Lead sponsor

Woman's

Other

Collaborators

  • Baton Rouge Area Foundation

Registry information

Official study title

Clinically Useful Methods for Assessment of Insulin Sensitivity and Beta Cell Function in Women at High Risk for Gestational Diabetes: Does Race Matter?

Acronym: DRM

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 30, 2008
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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