| Trial ID: | L4039 |
| Source ID: | NCT05280496
|
| Associated Drug: |
Metformin
|
| Title: |
A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes, Gestational|PreDiabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Metformin
|
| Outcome Measures: |
Primary: HbA1C, These results will be shared with participants and their providers. Any participants who accepted metformin but do not have diabetes will be asked to stop all study medication and no more study medication will be dispensed., 12 months|HbA1C, At 15 months postpartum, study participants with prediabetes will be seen again for their final study visit. The investigators intend to follow all participants for 3 months after metformin treatment ends for both safety reasons and efficacy reasons. If the metformin was masking diabetes, the investigators want the opportunity to identify those participants and refer them for treatment. Additionally, prior studies have not determined whether the benefits of metformin extend after the medication is discontinued (as indicated by the FDA when the investigators requested to use metformin in the first year postpartum)., 15 months | Secondary: Weight, 12 months|Weight, 15 months
|
| Sponsor/Collaborators: |
Sponsor: Tufts Medical Center
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2022-06-01
|
| Completion Date: |
2025-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-09-19
|
| Locations: |
Tufts Medical Center, Boston, Massachusetts, 02111, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05280496
|
