A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus

Women and Infants Hospital of Rhode Island

Status and phase: Unknown; Phase 3

Conditions: Gestational Diabetes

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04615351

1248906-9

Details and patient eligibility

About

A Pilot of Metformin Postpartum

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational Diabetes

Exclusion criteria

• Cannot tolerate metformin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Metformin

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Routine Care

No Intervention group

Description:

Discharge information about maintaining a healthy diet