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临床试验/NCT02304718
NCT02304718已完成不适用

Cycle Study:an Exercise Intervention to Prevent Gestational Diabetes in Overweight and Obese Chinese Pregnant Women

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
the risk of gestational diabetes mellitus

研究概览

简要总结

This study evaluates the role of exercise intervention in reducing the risk of gestational diabetes mellitus(GDM) risk of overweight/obese(prepregnancy BMI≥24kg/m^2) Chinese pregnant women. Half of participants will have exercise intervention, while the other half will not. Both of the two group will have regular prenatal care.

详细描述

An increasing number of women are entering pregnancy in an overweight or obese state. The overweight/obesity epidemic among women of reproductive age has led to an increasing incidence of gestational diabetes mellitus (GDM),and other metabolic and obstetric complications, such as fetal macrosomia, maternal obesity and type 2 diabetes.

Exercise may be a non-invasive therapeutic option for preventing and managing GDM that can be readily applied to the antenatal population.But so far, the effects of exercise interventions on the incidence of GDM and other adverse perinatal outcomes have been scarce, especially in Chinese pregnant women.

So the aim of the investigators study is to evaluate whether exercise intervention in overweight/obese(prepregnancy BMI≥24kg/m^2) Chinese pregnant women can reduce their risk of GDM and GDM related adverse pregnant outcomes.

Overweight/obese Chinese pregnant women (prepregnancy BMI≥24kg/m^2) will be randomly divided into exercise intervention group and control group in their first trimester(less than 13 gestational weeks), pregnant women randomised to the exercise intervention group will complete three supervised, exercise sessions each week by using a stational bike, and exercise sessions will be completed on alternate days. Both exercise group and control group have regular prenatal care.

During 24-28 gestatioanl weeks,GDM will be diagnosed by an oral glucose tolerance test (OGTT) according to the new World Health Organization criteria as fasting glucose level in fasting whole blood 5.1 mmol/L or more, or 2-hour value 8.5mmol/L or more.Then the investigators can compare the GDM risk in each group, and find out if exercise intervention can reduce the risk of GDM in overweight/obese Chinese pregnant 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 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Chinese overweight/obese(prepregnancy BMI≥24kg/m^2) pregnant women aged between 18 years and 45 years with a singleton live fetus.

排除标准

  • •High-risk pregnancies or diseases that could interfere with participation (or both), such as heart insufficiency, infectious diseases, cervical incompetence, multiple pregnancy,serious blood diseases, serious hypertension,absence of prenatal control, risk of premature labour.
  • •Prepregnant type 1 or 2 diabetes mellitus.
  • •Impaired glucose trolerance (IGT) and impaired fasting glucose(IFG)

研究组 & 干预措施

exercise intervention group

Experimental

Pregnant women randomised to the exercise intervention group will complete three supervised, exercise sessions each week, exercise sessions completed on alternate days, and lasts until they give birth by using a stational bike. And also they will have regular prenatal care.

干预措施: Stationary bike (Behavioral)

control group

No Intervention

Pregnant women randomised to the control group only have regular prenatal care.

结局指标

主要结局

the risk of gestational diabetes mellitus

时间窗: up to 24-28 gestational weeks

GDM will be diagnosed by an oral glucose tolerance test (OGTT) according to the new World Health Organization criteria as fasting glucose level in fasting whole blood 5.1 mmol/L or more, or 2-hour value 8.5mmol/L or more.Then we can use the rate of GDM ocurrence to represent the risk of gestational diabetes mellitus

次要结局

  • insulin resistance(up to 13, 26 and 39 gestatioanl weeks)
  • inflammatory factor(up to 13, 26 and 39 gestatioanl weeks)
  • weight gain(up to 42 gestatioanl weeks)
  • pregnancy outcome(up to 42 gestational weeks)
  • adipocytes(up to 13, 26 and 39 gestatioanl weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wang Chen

Ms

Peking University First Hospital

研究点 (1)

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