Skip to content

The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes

The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03550976
Enrollment
400
Registered
2018-06-11
Start date
2018-10-01
Completion date
2020-06-01
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Brief summary

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.

Interventions

BEHAVIORALThe low-GI diet and muscle training

During the 12-28 weeks of pregnancy, the pregnant women received low-GI diet and exercise intervention.Every two weeks, the pregnant women were followed up to assess the dietary situation and analyze the body composition results.Collect birth outcomes

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of gestational diabetes12-28 weeks of pregnancyThe 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.

Contacts

Primary ContactYanpin Liu, bachelor
liuyp1227@vip.sina.com+861069159088
Backup ContactYixuan Hou, master
15612494030@163.com+8618810112590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026