Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 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
- 否
入选标准
- •for early GDM women:
- •Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
- •Gestational diabetes mellitus identified at < 20 weeks' gestation requiring pharmacologic treatment (class A2)
排除标准
- •for early GDM women:
- •History of prediabetes or polycystic ovarian syndrome
- •History of pregestational type 2 diabetes mellitus
- •Skin conditions which prevent wearing a continuous glucose monitor
- •Inclusion Criteria for 3rd trimester GDM women:
- •Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
- •Gestational diabetes mellitus identified at >= 24 weeks' gestation requiring pharmacologic treatment (class A2)
- •Exclusion Criteria for 3rd trimester GDM women:
- •History of prediabetes or polycystic ovarian syndrome
- •History of pregestational type 2 diabetes mellitus
- •Skin conditions which prevent wearing a continuous glucose monitor
研究组 & 干预措施
Postpartum GDM
Women with GDM diagnosed early (< 20 weeks gestation) or with routine 3rd trimester screening (>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).
干预措施: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor (Diagnostic Test)
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
Ashley N. Battarbee
Assistant Professor
University of Alabama at Birmingham