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NCT Number: NCT02304718

Exercise Intervention to Prevent Gestational Diabetes

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.

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Key information

About this study

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.

Following,no matter pregnant women who were diagnosed with GDM in the intervention group or the control group,they will all have standard medical managemen, and continue what they do before until they give birth. That means pregnnat women in the intervention group will continue to have exercise intervention and regular prenatal care despite whether they have GDM or not.

So when they give birth, the investigators can compare pregnant outcomes between four groups, that is exercise group without GDM, exercise group with GDM, control group without GDM and control group with GDM.And the pregnant outcomes include preterm birth rates, fetal birth weight, Aparga score, cesarean rate and so on.

In this study, the investigators will also collect participants' blood samples in first, second and third trimester respectively,and collect cord blood samples, placenta samples,muscle samples and aidpose tissues when they give birh.Thus the investigators can also do some basic reasearch about the potential mechanisms of exercise in preventing GDM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Stationary bike

Behavioral

Primary outcomes

  1. the risk of gestational diabetes mellitus

    Time frame: 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

Secondary outcomes

  1. weight gain

    Time frame: up to 42 gestatioanl weeks

    use a same scale to measure pregnant women's weight before they give birth,and then subtract their weight prepregnancy. And also, we will use BMI increases as another indicator in representing their weight gain

  2. insulin resistance

    Time frame: up to 13, 26 and 39 gestatioanl weeks

    measure the insulin concentration in the serum of pregnant women in the early(before 13 gestational weeks), mid( between 25-26 gestatianl weeks)and late-term(between 37-39 gestatioanl weeks) of pregnancy, and define their homeostatic model assessments for insulin resistance (HOMA-IR)

  3. adipocytes

    Time frame: up to 13, 26 and 39 gestatioanl weeks

    measure the adipocytes concentrations in the serum of pregnant women in the early(before 13 gestational weeks), mid( between 25-26 gestatianl weeks)and late-term(between 37-39 gestatioanl weeks) of pregnancy, also measure them in the cord blood serum by ELISA.

  4. inflammatory factor

    Time frame: up to 13, 26 and 39 gestatioanl weeks

    measure the inflammatory factor concentrations in the serum of pregnant women in the early(before 13 gestational weeks), mid( between 25-26 gestatianl weeks)and late-term(between 37-39 gestatioanl weeks) of pregnancy, also measure them in the cord blood serum by ELISA.

  5. pregnancy outcome

    Time frame: up to 42 gestational weeks

    collect data about birth weight, Aparga score, duration of pregnancy and delivery mode

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2014
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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