A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prediabetes or Diabetes
研究概览
简要总结
A Pilot of Metformin Postpartum
详细描述
The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gestational Diabetes
排除标准
- •Cannot tolerate metformin
研究组 & 干预措施
Metformin
Metformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose
干预措施: Metformin (Drug)
结局指标
主要结局
Prediabetes or Diabetes
时间窗: 1 year postpartum
glycosylated hemoglobin (HgbA1c) at 1 year postpartum (\>/= 5.7% defined as prediabetes, \>/=6.5% defined as DM
次要结局
- Prediabetes or diabetes at 15 months postpartum(15 months after delivery and study initiation)