A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
- Registration Number
- NCT04615351
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- Brief Summary
A Pilot of Metformin Postpartum
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
- Gestational Diabetes
- Cannot tolerate metformin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin 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
- Primary Outcome Measures
Name Time Method Prediabetes or Diabetes 1 year postpartum glycosylated hemoglobin (HgbA1c) at 1 year postpartum (\>/= 5.7% defined as prediabetes, \>/=6.5% defined as DM
- Secondary Outcome Measures
Name Time Method Prediabetes or diabetes at 15 months postpartum 15 months after delivery and study initiation HgbA1c at 15 months postpartum
Trial Locations
- Locations (1)
Women & Infants Hospital
🇺🇸Providence, Rhode Island, United States