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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Gestational Diabetes

Treatments: Behavioral: The low-GI diet and muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT03550976

hs-1551

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

High risk intervention group

Experimental group

Treatment:

Behavioral: The low-GI diet and muscle training

High risk control group

No Intervention group

Description:

Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.

Low risk control group

No Intervention group

Description:

Dietary evaluation and body composition analysis at 12 and 28 weeks of pregnancy. Receive routine obstetric examinations and routine health education which includes proper diet and exercise advice.Collect birth outcomes.