NCT05280496CompletedPhase 3
A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes
Implementation of a Pragmatic Approach to Lower Diabetes Mellitus Risk After a Diagnosis of Gestational Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 20 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 3 Mar 2022
- Start date
- Jun 2022
- Primary completion date
- Mar 2025
- Lead sponsor
- Tufts Medical Center
- Diseases
- Type 2 diabetes
- NCT number
- NCT05280496
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 20
- From Jun 2022 to the primary completion date, Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Preexisting diabetes mellitus.
Lab values
- Contraindications to metformin
- Liver disease
- Impaired renal function (Creatinine Clearance\> )
- Congestive heart failure(CHF)
- Taking drugs that could interfere with metformin metabolism
- Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids).
Other
- Unable to commit to required study visits for any reason.
- Taking metformin outside of pregnancy
- Decided against the 2 hour 75 gram OGTT during postpartum hospitalization.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.