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Weight Changes During and After Pregnancy in Women With Gestational Diabetes

2017年1月18日 更新者:Rosette Chakkalakal、Vanderbilt University
Gestational diabetes mellitus (GDM) is associated with short-term and long-term complications for infants and mothers. The management of GDM during pregnancy focuses on reducing risks to the infant associated with hyperglycemia. The postpartum management of GDM focuses on reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM identifies up to 31% of parous women who will eventually develop T2DM and approximately 50% of women diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived risk of developing short-term and/or long-term complications of GDM may influence women's likelihood of engaging in diet modification, the mainstay of treatment of GDM, both during and after pregnancy. If sustained after delivery, diet modifications introduced as treatment for GDM could affect maternal weight changes during and after pregnancy, which could in turn affect T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of developing T2DM, dietary choices, or weight gain (and retention) during versus after pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the perceived risk of developing T2DM among women with GDM during and after pregnancy, (2) characterize dietary choices of women with GDM during and after pregnancy, and (3) characterize weight changes of women with GDM during and after pregnancy as compared to women without GDM.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

89

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Tennessee
      • Nashville、Tennessee、美国、37232-8300
        • Vanderbilt University Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

All women receiving prenatal care at Vanderbilt University Medical Center who do not already carry a diagnosis of type 1 or type 2 diabetes are screened for GDM between weeks 24-28 of pregnancy with a non-fasting 50-gram glucose tolerance test (GTT). Blood glucose values greater than or equal to 140 on this screening test are considered positive. Women with a positive screening test undergo a diagnostic fasting 100-gram 3-hour GTT. GDM is diagnosed if a woman has 2 or more abnormal values on the 3-hour GTT (abnormal values are fasting blood glucose greater than or equal to 95, 1-hour blood glucose greater than or equal to 180, 2-hour blood glucose greater than or equal to 155 and/or 3-hour blood glucose greater than or equal to 140). By reviewing the electronic medical record of women with singleton pregnancies undergoing GTT on a weekly basis, we will identify women with and without GDM.

描述

Inclusion Criteria for women with GDM:

  • Patient is currently pregnant with a singleton pregnancy.
  • Laboratory confirmed diagnosis of GDM between weeks 24-28 gestation.
  • Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

Inclusion Criteria for women without GDM:

  • Patient is currently pregnant with a singleton pregnancy.
  • Patient does not have GDM based on non-fasting and/or fasting GTT results.
  • Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

Exclusion Criteria for both cohorts:

  • Diagnosis of type 1 or type 2 diabetes prior to pregnancy.
  • Diagnosis of GDM prior to 20 weeks gestation.
  • Patient does not speak English.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
患有 GDM 的女性
没有 GDM 的女性

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Postpartum weight change measured in kilograms
大体时间:6 months (change in weight from the time of delivery to 6 months postpartum)
6 months (change in weight from the time of delivery to 6 months postpartum)

次要结果测量

结果测量
大体时间
Rate of pregnancy weight gain prior to GDM diagnosis measured in kilograms per week
大体时间:24-28 weeks
24-28 weeks
Rate of pregnancy weight gain after GDM diagnosis measured in kilograms per week
大体时间:10-16 weeks
10-16 weeks
Change in perceived risk of developing diabetes during versus after pregnancy measured with the Risk Perception Survey for Developing Diabetes (RPS-DD)
大体时间:10 months
10 months
Change in dietary choices during versus after pregnancy measured with the Personal Diabetes Questionnaire
大体时间:10 months
10 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rosette Chakkalakal, MD、Vanderbilt University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年6月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2016年12月1日

研究注册日期

首次提交

2015年3月9日

首先提交符合 QC 标准的

2015年3月9日

首次发布 (估计)

2015年3月17日

研究记录更新

最后更新发布 (估计)

2017年1月20日

上次提交的符合 QC 标准的更新

2017年1月18日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 140295
  • P30DK092986 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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