Myo-inositol May Prevent Gestational Diabetes in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- number of gestational diabetes cases diagnosed with OGTT
研究概览
简要总结
Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. This is a prospective, randomized, double center, placebo-controlled study. Two hundred and twenty obese pregnant women will be included in the trial and, after an informed consent, will assume randomly 2 g of myo-inositol twice a day or placebo from 12-13th weeks gestation until delivery. Then,they will perform an Oral Glucose Tolerance Test (OGTT) at 24-28th weeks gestation. Records about delivery (gestational age, neonatal weight...) will be registered.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese pregnant women: BMI > 30 Kg/cm2
- •first trimester fast glycaemia < 126 mg/dl
- •single pregnancy
排除标准
- •Pregnant women with BMI < 30 Kg/cm2
- •first trimester fast glycaemia > 126 mg/dl
- •previous gestational diabetes
- •twin pregnancy
- •pregestational diabetes
- •associated therapies with corticosteroids
结局指标
主要结局
number of gestational diabetes cases diagnosed with OGTT
时间窗: 24-28th weeks gestation
difference in HOMA values
时间窗: from first trimester to OGTT
次要结局
- incidence of pregnancy complications: hypertension, preterm delivery. macrosomia, shoulder dystocia, etc.(at delivery)
研究者
Rosario D'anna
associate professor
University of Messina