Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.
There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.
Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.
Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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-
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Mexico、墨西哥、11000
- National Institute of Perinatology
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
- Body mass index > 27 kg/m2
- Maternal age >25
- History of infertility with polycystic ovary syndrome
- History of macrosomic newborn (Weight >4000g)
- History of diabetes mellitus in first or second degree.
- History of gestational diabetes in previous pregnancy
Exclusion Criteria:
- Any form of pregestational diabetes
- Fasting glucose > 126 mg/dL at first prenatal visit.
- seric creatinine > 1.5 mg/dL
- Hyperthyroidism
- Heart disease
- Hepatic disease
- Renal diseases
- Epilepsy
- Lupus
- Chronic hypertension.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：medical nutrition therapy + metformin
medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
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|
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有源比较器：medical nutrition therapy
medical nutrition therapy without trans-gestational metformin
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medical nutrition therapy
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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 |
|---|---|---|
|
Gestational diabetes mellitus
大体时间：27-28 weeks of gestation
|
oral glucose tolerance test
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27-28 weeks of gestation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
insulin resistance
大体时间：At birth
|
measure of insulin resistance by HOMA-IR, sample of umbilical cord
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At birth
|
合作者和调查者
调查人员
- 首席研究员：Enrique Reyes-Muñoz, PhD、National Institute of Perinatology, Mexico City
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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