D-chiro Inositol in Prevention of Gestational Diabetes Mellitus in High Risk Pregnant Women in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- the incidence of gestational diabetes
研究概览
简要总结
Inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. Our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly 1 g of D-chiro inositol per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about delivery time, 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
- Double (Participant, Care Provider)
盲法说明
The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office.
When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book.
If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
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
- •During 12-16 weeks gestation
- •Meet any of the following: prepregnancy BMI > 24, family history of diabetes (type 1 or 2), GDM history, history of delivering macrosomia, gestational history of stillbirth;
- •Willing to participate
排除标准
- •Type 1 or type 2 diabetes mellitus diagnosed before pregnancy
- •Multiple gestation
- •Mental or cognitive impairment cannot complete the study
结局指标
主要结局
the incidence of gestational diabetes
时间窗: 24-28th weeks gestation
The number of cases and incidence of gestational diabetes according to OGTT
次要结局
- the perinatal outcomes-2(Delivery)
- the perinatal outcomes-3(Delivery)
- the perinatal outcomes-1(Delivery)