The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Weight Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Placebo
Compounded placebo
干预措施: Placebo (Drug)
Metformin
Compounded metformin as the intervention
干预措施: Metformin (Drug)
结局指标
主要结局
Weight Change
时间窗: 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)
次要结局
- Difficulty With Exercise 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)
- 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)
- HDL, LDL, Triglyceride(At 6 weeks postpartum)
- 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)
研究者
Jerrie Refuerzo
Associate Professor
The University of Texas Health Science Center, Houston