Metformin Postpartum for GDM
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother. |
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| Condition | Diabetes, Gestational |
| Intervention | Drug: Metformin Drug: Placebo |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center, Houston |
| Responsible Party | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier | NCT01280409 |
| First Received | January 19, 2011 |
| Last Updated | May 18, 2011 |
| Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 19, 2011 |
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| Last Updated Date | May 18, 2011 |
| Start Date | January 2011 |
| Estimated Primary Completion Date | April 2013 |
| Current Primary Outcome Measures | Weight Change [Time Frame: At 6 weeks postpartum visit (2nd research visit)] [Designated as safety issue: No]The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk) |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin Postpartum for GDM |
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| Official Title | The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial |
| Brief Summary | The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother. |
| Detailed Description | At 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. Maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. Women will be counseled regarding diet, exercise and glucose control. Data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. At 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. At 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. Finally, a satisfaction survey will be completed. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Diabetes, Gestational |
| Intervention | Drug: Metformin Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks Drug: Placebo Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 80 |
| Estimated Completion Date | April 2013 |
| Estimated Primary Completion Date | February 2013 |
| Eligibility Criteria | Inclusion Criteria: - Postpartum women with a delivery greater than 34 weeks of pregnancy - Between the ages of 18 to 49 years - Women with a diagnosis of gestational diabetes mellitus (either treated with insulin, oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy based on a confirmatory 3 hour glucola test (based on either the Carpenter and Coustan's of the Diabetes Task Force criteria) Exclusion Criteria: - women with pre-gestational diabetes mellitus (either Type I or Type II DM) - women unable to tolerate metformin based on patient history - women who will be discharged hom eon insulin or oral hypoglycemic agent in the immediate postpartum period - women with a BMI <25 kg/m² |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Jerrie S Refuerzo, MD 713.500.6416 Jerrie.S.Refuerzo@uth.tmc.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01280409 |
|---|---|
| Other Study ID Numbers | HSC-MS-10-0426 |
| Has Data Monitoring Committee | No |
| Information Provided By | The University of Texas Health Science Center, Houston |
| Study Sponsor | The University of Texas Health Science Center, Houston |
| Collaborators | Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research |
| Investigators | Principal Investigator: Jerrie S Refuerzo, MD The University of Texas Health Science Center, Houston |
| Verification Date | May 2011 |
Locations[ + expand ][ + ]
| Memorial Hermann Hospital, Texas Medical Center | Houston, Texas, United States, 77030 Contact: Jerrie S Refuerzo, MD | 713-500-6416 | Jerrie.S.Refuerzo@uth.tmc.eduRecruiting |
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| University of Texas Health Science Center at Houston, Professional Building | Houston, Texas, United States, 77030 Contact: Jerrie S Refuerzo, MD | 713-500-6416 | Jerrie.S.Refuerzo@uth.tmc.eduRecruiting |