CompletedPhase 3

A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes

United States20 participantsStarted 2022-06-01

Plain-language summary

This study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Women currently pregnant with planned delivery at Tufts Medical Center
✓. Gestational diabetes mellitus diagnosed during pregnancy
✓. ≥18 years of age
✓. Opted for the 2 hour 75 gram OGTT during postpartum hospitalization
✓. Willing and able to sign the informed consent

Exclusion criteria

✕. Unable to commit to required study visits for any reason.
✕. Contraindications to metformin
✕. Taking metformin outside of pregnancy
✕. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids).
✕. Decided against the 2 hour 75 gram OGTT during postpartum hospitalization.
✕. Preexisting diabetes mellitus.

What they're measuring

HbA1C

Timeframe: 12 months

HbA1C

Timeframe: 15 months

Trial details

NCT IDNCT05280496

SponsorTufts Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Diabetes, Gestational trials