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临床试验/NCT00687479
NCT00687479已完成不适用

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

Woman's1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
175
试验地点
1
主要终点
Insulin action measures

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • <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

结局指标

主要结局

Insulin action measures

时间窗: 20-30 weeks of pregnancy

次要结局

  • infant gestational age(time of delivery)

研究者

发起方
Woman's
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Elkind-Hirsch

Director of Research

Woman's

研究点 (1)

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