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

Primary Purpose

Gestational Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The low-GI diet and muscle training
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    No Intervention

    Arm Label

    High risk intervention group

    High risk control group

    Low risk control group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 29, 2018
    Last Updated
    August 6, 2018
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03550976
    Brief Title
    The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
    Official Title
    The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    September 10, 2019 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High risk intervention group
    Arm Type
    Experimental
    Arm Title
    High risk control group
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Low risk control group
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    The low-GI diet and muscle training
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Incidence of gestational diabetes
    Description
    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.
    Time Frame
    12-28 weeks of pregnancy

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanpin Liu, bachelor
    Phone
    +861069159088
    Email
    liuyp1227@vip.sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yixuan Hou, master
    Phone
    +8618810112590
    Email
    15612494030@163.com

    12. IPD Sharing Statement

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

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