Status:
RECRUITING
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Lead Sponsor:
George Washington University
Collaborating Sponsors:
University of North Carolina
Diabetes Sisters
Conditions:
Weight Loss
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within t...
Detailed Description
Once enrollment is complete (consent signed), participants will complete the baseline online medical history form and 9 questionnaires available online. Baseline: Participants will come for an in-per...
Eligibility Criteria
Inclusion
- Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by GDM will be recruited. The research team will begin recruiting women who are at least 8 weeks postpartum to provide time to describe the study and answer any questions. Mothers who want to participate will be enrolled in the study between 12 weeks and 12 months postpartum.
- BMI of 25 kg/m2 to 45 kg/m2
- Singleton delivery
- Participants must also have a working cell phone, be willing to accept email or text messages attend Zoom calls, and be willing to be potentially randomized to drug therapy with Metformin.
Exclusion
- Pregnant or planned pregnancy within the next 6 months.
- Participation in any other weight loss program or taking weight loss medication.
- Normal or underweight BMI (BMI \< 24.9 kg/m2)
- Multi-fetal (twins or triplets) gestation
- Women with type 1 or type 2 diabetes, malignancy, other serious co-morbidities (advanced kidney disease, NYHA class 3-4 CHF, advanced COPD), schizophrenia or other major psychiatric disease, and substance abuse or AIDS.
- Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06948825
Start Date
November 1 2025
End Date
August 1 2026
Last Update
September 19 2025
Active Locations (1)
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1
Milken Institute School of Public Health - The George Washington University
Washington D.C., District of Columbia, United States, 20052