Metformin Postpartum for GDM RCT for Reduced Weight Retention
2018年11月1日 更新者：Jerrie Refuerzo、The University of Texas Health Science Center, Houston
The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
114
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- Memorial Hermann Hospital, Texas Medical Center
-
Houston、Texas、美国、77030
- University of Texas Health Science Center at Houston, Professional Building
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 49年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
Compounded placebo
|
Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
|
|
实验性的：Metformin
Compounded metformin as the intervention
|
Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weight Change
大体时间：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) |
within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Achieved Pre-pregnancy Weight
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Number of Participants Who Achieved Their Ideal Body Weight
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Hemoglobin a1c
大体时间：At 6 weeks postpartum
|
We will calculate the change in hemoglobin a1c.
|
At 6 weeks postpartum
|
|
HDL, LDL, Triglyceride
大体时间：At 6 weeks postpartum
|
We will calculate the change in LDL, HDL, and triglyceride levels.
|
At 6 weeks postpartum
|
|
Self-reported Compliance With Medications
大体时间：3 weeks postpartum
|
3 weeks postpartum
|
|
|
Self-reported Compliance With Medications
大体时间：6 weeks postpartum
|
6 weeks postpartum
|
|
|
Difficulty With Diet as Assessed by a 5-point Likert Scale
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Difficulty With Exercise as Assessed by a 5-point Likert Scale
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Difficulty With Medication as Assessed by a 5-point Likert Scale
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Satisfaction With Diet as Assessed by a 5-point Likert Scale
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Satisfaction With Exercise as Assessed by a 5-point Likert Scale
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
|
|
Satisfaction With Medication as Assessed by a 5-point Likert Scale
大体时间：At 6 weeks postpartum
|
At 6 weeks postpartum
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jerrie S Refuerzo, MD、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2014年3月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2011年1月19日
首先提交符合 QC 标准的
2011年1月19日
首次发布 (估计)
2011年1月20日
研究记录更新
最后更新发布 (实际的)
2018年11月28日
上次提交的符合 QC 标准的更新
2018年11月1日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.