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Clinical Trials/NCT03550976
NCT03550976
Unknown
Not Applicable

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

Peking Union Medical College Hospital0 sites400 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Peking Union Medical College Hospital
Enrollment
400
Primary Endpoint
Incidence of gestational diabetes
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
June 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liuyanping

Clinical Professor

Peking Union Medical College Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Incidence of gestational diabetes

Time Frame: 12-28 weeks of pregnancy

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.

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