Metformin Postpartum for GDM
Recruitment status was Recruiting
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes, Gestational |
Drug: Metformin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial |
- 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)
- Achievement of pre-pregnancy weight [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]We will calculate the percentage of women that achieve their self-reported pre-pregnancy weight.
- Ideal Body weight [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]We will calculate the percentage of women that achieve their ideal body weight.
- Hemoglobin a1c [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]We will calculate the change in hemoglobin a1c.
- HDL, LDL, triglyceride [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]We will calculate the change in LDL, HDL, and triglyceride levels.
- Satisfaction Survey [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]Results of the satisfaction survey will be analyzed.
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
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.
|
| Experimental: Metformin |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jerrie S Refuerzo, MD | 713.500.6416 | Jerrie.S.Refuerzo@uth.tmc.edu |
| Contact: Maria S Hutchinson, MS | 713.500.5850 | Maria.S.Keefer@uth.tmc.edu |
| United States, Texas | |
| Memorial Hermann Hospital, Texas Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jerrie S Refuerzo, MD 713-500-6416 Jerrie.S.Refuerzo@uth.tmc.edu | |
| University of Texas Health Science Center at Houston, Professional Building | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jerrie S Refuerzo, MD 713-500-6416 Jerrie.S.Refuerzo@uth.tmc.edu | |
| Principal Investigator: | Jerrie S Refuerzo, MD | The University of Texas Health Science Center, Houston |
More Information
No publications provided
| Responsible Party: | Jerrie Refuerzo, MD, University of Texas Health Science Center at Houston |
| ClinicalTrials.gov Identifier: | NCT01280409 History of Changes |
| Other Study ID Numbers: | HSC-MS-10-0426 |
| Study First Received: | January 19, 2011 |
| Last Updated: | May 18, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pregnancy Complications Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013