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临床试验/NCT04521712
NCT04521712已完成不适用

Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

University of Alabama at Birmingham4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
Pancreatic beta cell function

研究概览

简要总结

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Pancreatic beta cell function

时间窗: 4-6 weeks after delivery

Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.

次要结局

  • Maternal glycemia measured by CGM(10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery)
  • Pancreatic beta cell function(0-4 days and 6 months after delivery)
  • Maternal diabetes mellitus(4-6 weeks and 6 months after delivery)
  • Maternal glucose variability(10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery)
  • Maternal and infant body fat composition(0-4 days, 4-6 weeks, and 6 months after delivery)
  • Maternal hyperglycemia measured by CGM(10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley N. Battarbee

Assistant Professor

University of Alabama at Birmingham

研究点 (4)

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