Status:
COMPLETED
A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes
Lead Sponsor:
Tufts Medical Center
Conditions:
Diabetes, Gestational
PreDiabetes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 cou...
Detailed Description
Women with a history of gestational diabetes mellitus (GDM) represent a unique population who may benefit from metformin as much as lifestyle intervention; when metformin is prescribed to these women ...
Eligibility Criteria
Inclusion
- 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
- Unable to commit to required study visits for any reason.
- Contraindications to metformin
- Liver disease
- Impaired renal function (Creatinine Clearance\> )
- Congestive heart failure(CHF)
- Taking drugs that could interfere with metformin metabolism
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05280496
Start Date
June 1 2022
End Date
April 18 2025
Last Update
April 20 2025
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111