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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gestational Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-NGT<br>normal glucose tolerance | |
| 2-GDM<br>Gestational Diabetes mellitus | |
| 3.GIGT<br>Gestational Impaired glucose tolerance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin action measures |  | 20-30 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant gestational age |  | time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin sensitivity, insulin secretion, infant outcome