The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Incidence of gestational diabetes
研究概览
简要总结
The incidence of gestational diabetes increased.The multidisciplinary management of GDM during pregnancy is helpful to improve the pregnancy outcome, but it will occupy huge medical resources.Early prediction, diet and exercise interventions can reduce the incidence of gestational diabetes, but there is no reliable way to predict and intervene early.This study is a randomized controlled trials, and aims to use comprehensive prediction method (genetic screening, body composition, clinical risk factors screening) screening the subjects with high GDM risk in early pregnancy, conducting diet and exercise intervention in second trimester and observing the effect on the incidence of GDM and perinatal outcomes.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •early pregnant women (< 12 weeks)
- •fasting blood glucose < / = 5.6 mmol/L and glycosylated hemoglobin < / = 5.6%
- •prepregnancy overweight (BMI > 23.9) or body fat content more than 30% (based on body composition analysis)
- •no history of major diseases or long-term drug treatment
- •no obvious physical disabilities, the ability of physical activity is normal
- •dietary behavior and mental is normal
- •resident in Beijing, early and middle stage pregnancy can be in Beijing area to receive regular obstetric examinations
- •signed informed consent
- •the following at least one
- •first-degree relatives family history of diabetes
- •history of abnormal lipid metabolism or abnormal lipid metabolism
- •history of polycystic ovary syndrome
- •history of large for gestational age infant or macrosomia deliver
排除标准
- •history of gestational diabetes mellitus
- •clinical glucose metabolism abnormalities
- •once taking diabetes drugs or insulin injections
- •a variety of food allergies or food choices serious limitations
- •exercise during pregnancy contraindication
研究组 & 干预措施
High risk intervention group
干预措施: The low-GI diet and muscle training (Behavioral)
High risk control group
Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.
Low risk control group
Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.
结局指标
主要结局
Incidence of gestational diabetes
时间窗: 12-28 weeks of pregnancy
The incidence of GDM was compared between the low-GI diet and the muscle training group, the high-risk control group and the low-risk control group.
次要结局
未报告次要终点
研究者
Liuyanping
Clinical Professor
Peking Union Medical College Hospital