A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Women currently pregnant with planned delivery at Tufts Medical Center

2. Gestational diabetes mellitus diagnosed during pregnancy

3. ≥18 years of age

4. Opted for the 2 hour 75 gram OGTT during postpartum hospitalization

5. Willing and able to sign the informed consent

Exclusion Criteria:

1. Unable to commit to required study visits for any reason.

2. Contraindications to metformin

• Liver disease

• Impaired renal function (Creatinine Clearance> )

• Congestive heart failure(CHF)

• Taking drugs that could interfere with metformin metabolism

3. Taking metformin outside of pregnancy

4. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids).

5. Decided against the 2 hour 75 gram OGTT during postpartum hospitalization.

6. Preexisting diabetes mellitus.