Metformin Postpartum for GDM RCT for Reduced Weight Retention
- Registration Number
- NCT01280409
- Lead Sponsor
- The University of Texas Health Science Center, Houston
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 114
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Compounded placebo Metformin Metformin Compounded metformin as the intervention
- Primary Outcome Measures
Name Time Method Weight Change within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit) The weight change in kilograms defined as:
weight change = Weight(pp) - Weight(6wk)
- Secondary Outcome Measures
Name Time Method Difficulty With Exercise as Assessed by a 5-point Likert Scale At 6 weeks postpartum Satisfaction With Exercise as Assessed by a 5-point Likert Scale At 6 weeks postpartum Satisfaction With Medication as Assessed by a 5-point Likert Scale At 6 weeks postpartum Number of Participants Who Achieved Pre-pregnancy Weight At 6 weeks postpartum Number of Participants Who Achieved Their Ideal Body Weight At 6 weeks postpartum Hemoglobin a1c At 6 weeks postpartum We will calculate the change in hemoglobin a1c.
HDL, LDL, Triglyceride At 6 weeks postpartum We will calculate the change in LDL, HDL, and triglyceride levels.
Difficulty With Medication as Assessed by a 5-point Likert Scale At 6 weeks postpartum Satisfaction With Diet as Assessed by a 5-point Likert Scale At 6 weeks postpartum Self-reported Compliance With Medications 6 weeks postpartum Difficulty With Diet as Assessed by a 5-point Likert Scale At 6 weeks postpartum
Trial Locations
- Locations (2)
Memorial Hermann Hospital, Texas Medical Center
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston, Professional Building
🇺🇸Houston, Texas, United States