Exercise Intervention to Prevent Gestational Diabetes
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stationary bike
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring GDM, pregnancy outcome, obesity, exercise, overweight
Eligibility 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)
Sites / Locations
- Peking University First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercise intervention group
control group
Arm Description
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.
Pregnant women randomised to the control group only have regular prenatal care.
Outcomes
Primary Outcome Measures
the risk of gestational diabetes mellitus
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
weight gain
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
insulin resistance
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)
adipocytes
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.
inflammatory factor
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.
pregnancy outcome
collect data about birth weight, Aparga score, duration of pregnancy and delivery mode
Full Information
NCT ID
NCT02304718
First Posted
November 24, 2014
Last Updated
August 31, 2016
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02304718
Brief Title
Exercise Intervention to Prevent Gestational Diabetes
Official Title
Cycle Study:an Exercise Intervention to Prevent Gestational Diabetes in Overweight and Obese Chinese Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
GDM, pregnancy outcome, obesity, exercise, overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Pregnant women randomised to the control group only have regular prenatal care.
Intervention Type
Behavioral
Intervention Name(s)
Stationary bike
Primary Outcome Measure Information:
Title
the risk of gestational diabetes mellitus
Description
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
Time Frame
up to 24-28 gestational weeks
Secondary Outcome Measure Information:
Title
weight gain
Description
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
Time Frame
up to 42 gestatioanl weeks
Title
insulin resistance
Description
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)
Time Frame
up to 13, 26 and 39 gestatioanl weeks
Title
adipocytes
Description
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.
Time Frame
up to 13, 26 and 39 gestatioanl weeks
Title
inflammatory factor
Description
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.
Time Frame
up to 13, 26 and 39 gestatioanl weeks
Title
pregnancy outcome
Description
collect data about birth weight, Aparga score, duration of pregnancy and delivery mode
Time Frame
up to 42 gestational weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-mei Wei, MD
Organizational Affiliation
Mrs
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chen Wang, PhD
Organizational Affiliation
Ms
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24518194
Citation
Halse RE, Wallman KE, Newnham JP, Guelfi KJ. Home-based exercise training improves capillary glucose profile in women with gestational diabetes. Med Sci Sports Exerc. 2014 Sep;46(9):1702-9. doi: 10.1249/MSS.0000000000000302.
Results Reference
background
PubMed Identifier
24037671
Citation
Yin YN, Li XL, Tao TJ, Luo BR, Liao SJ. Physical activity during pregnancy and the risk of gestational diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2014 Feb;48(4):290-5. doi: 10.1136/bjsports-2013-092596. Epub 2013 Sep 13.
Results Reference
background
PubMed Identifier
20876206
Citation
Tobias DK, Zhang C, van Dam RM, Bowers K, Hu FB. Physical activity before and during pregnancy and risk of gestational diabetes mellitus: a meta-analysis. Diabetes Care. 2011 Jan;34(1):223-9. doi: 10.2337/dc10-1368. Epub 2010 Sep 27.
Results Reference
background
PubMed Identifier
24996985
Citation
Kaar JL, Crume T, Brinton JT, Bischoff KJ, McDuffie R, Dabelea D. Maternal obesity, gestational weight gain, and offspring adiposity: the exploring perinatal outcomes among children study. J Pediatr. 2014 Sep;165(3):509-15. doi: 10.1016/j.jpeds.2014.05.050. Epub 2014 Jul 1.
Results Reference
background
PubMed Identifier
21955004
Citation
Singh J, Huang CC, Driggers RW, Timofeev J, Amini D, Landy HJ, Miodovnik M, Umans JG. The impact of pre-pregnancy body mass index on the risk of gestational diabetes. J Matern Fetal Neonatal Med. 2012 Jan;25(1):5-10. doi: 10.3109/14767058.2012.626920. Epub 2011 Nov 9.
Results Reference
background
PubMed Identifier
23494259
Citation
You T, Arsenis NC, Disanzo BL, Lamonte MJ. Effects of exercise training on chronic inflammation in obesity : current evidence and potential mechanisms. Sports Med. 2013 Apr;43(4):243-56. doi: 10.1007/s40279-013-0023-3.
Results Reference
background
PubMed Identifier
24563869
Citation
Golbidi S, Laher I. Exercise induced adipokine changes and the metabolic syndrome. J Diabetes Res. 2014;2014:726861. doi: 10.1155/2014/726861. Epub 2014 Jan 19.
Results Reference
background
PubMed Identifier
27660125
Citation
Wang C, Wei Y, Zhang X, Zhang Y, Xu Q, Su S, Zhang L, Liu C, Feng Y, Shou C, Guelfi KJ, Newnham JP, Yang H. Effect of Regular Exercise Commenced in Early Pregnancy on the Incidence of Gestational Diabetes Mellitus in Overweight and Obese Pregnant Women: A Randomized Controlled Trial. Diabetes Care. 2016 Oct;39(10):e163-4. doi: 10.2337/dc16-1320. No abstract available.
Results Reference
derived
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Exercise Intervention to Prevent Gestational Diabetes
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