Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise Intervention to Prevent Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02304718
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Wang Chen, Peking University First Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: Stationary bike Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cycle Study:an Exercise Intervention to Prevent Gestational Diabetes in Overweight and Obese Chinese Pregnant Women
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: exercise intervention group
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.
Behavioral: Stationary bike
No Intervention: control group
Pregnant women randomised to the control group only have regular prenatal care.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304718


Locations
Layout table for location information
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yu-mei Wei, MD Mrs
Principal Investigator: Chen Wang, PhD Ms
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Wang Chen, Ms, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02304718    
Other Study ID Numbers: 400010558
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wang Chen, Peking University First Hospital:
GDM
pregnancy outcome
obesity
exercise
overweight
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications