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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03550976
• Other study ID #: hs-1551
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: August 2018
• Source: Peking Union Medical College Hospital
• Contact: Yanpin Liu, bachelor
• Phone: +861069159088
• Email: liuyp1227[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• The 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

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