EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Gestational diabetes mellitus
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Chronic hypertension.
研究组 & 干预措施
medical nutrition therapy + metformin
medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
干预措施: medical nutrition therapy + metformin (Drug)
medical nutrition therapy
medical nutrition therapy without trans-gestational metformin
干预措施: Medical nutrition therapy (Behavioral)
结局指标
主要结局
Gestational diabetes mellitus
时间窗: 27-28 weeks of gestation
oral glucose tolerance test
次要结局
- insulin resistance(At birth)
研究者
ENRIQUE REYES-Munoz MD
Clinical Reseach
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes