Gestational Diabetes Clinical Trial
Official title:
The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | June 1, 2020 |
Est. primary completion date | September 10, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of gestational diabetes | 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. | 12-28 weeks of pregnancy |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05081037 -
Integrated Hyperglycaemia Incentivised Postnatal Surveillance Study (I-HIPS)
|
N/A | |
Active, not recruiting |
NCT03249896 -
Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes
|
N/A | |
Terminated |
NCT03749889 -
Low Carb vs Normal Carb in Pregnancy
|
N/A | |
Completed |
NCT03859193 -
Education Nutritional Video for Gestational Diabetics
|
N/A | |
Recruiting |
NCT05037526 -
Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
|
N/A | |
Completed |
NCT06178250 -
Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester
|
N/A | |
Not yet recruiting |
NCT06445530 -
Nutrition Optimization and Community Upliftment for Postpartum Recovery
|
N/A | |
Not yet recruiting |
NCT06310356 -
Continuous Glucose Monitoring for Women With Gestational Diabetes
|
N/A | |
Recruiting |
NCT02590016 -
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
|
Phase 4 | |
Not yet recruiting |
NCT00883259 -
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
|
Phase 4 | |
Withdrawn |
NCT01947699 -
Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide
|
Phase 4 | |
Recruiting |
NCT03008824 -
Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby
|
N/A | |
Active, not recruiting |
NCT01340924 -
Relationship Between Gestational Diabetes and Type 2 Diabetes
|
||
Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
Recruiting |
NCT00371306 -
Comparison of Glucovance to Insulin for Diabetes During Pregnancy
|
N/A | |
Completed |
NCT03388723 -
Intergenerational Programming of Diabesity in Offspring of Women With Gestational Diabetes Mellitus
|
||
Recruiting |
NCT04521712 -
Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia
|
N/A | |
Enrolling by invitation |
NCT03307486 -
Gestational Diabetes: a Cohort Study
|
N/A | |
Active, not recruiting |
NCT03301792 -
Group Versus Traditional Prenatal Care for Diabetes
|
N/A | |
Enrolling by invitation |
NCT05603793 -
YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
|