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Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rice-richen meal
wheaten-richen meal
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women who undergo health examination in obstetric department in Peking Union Medical College Hospital.
  • 20-45 years old.
  • Pregnant women who are diagnosed with GDM according to the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria during 24-28 weeks.
  • Be ability to use mobile medical equipment, conditional follow-up of the mother and child.
  • Voluntary participation in this study.

Exclusion Criteria:

  • Multiple pregnancy.
  • Merger of serious diseases (such as hypertension, respiratory diseases, kidney disease, abnormal coagulation, immune system diseases, infectious diseases), history of adverse pregnancy (such as spontaneous abortion, habitual abortion), and history of GDM.
  • Pregnant women with known diabetes before pregnancy, those requiring insulin or hormone therapy.
  • Pregnant women who are deemed inappropriate to participate in this clinical study by her physician.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    rice-richen meal

    wheaten-richen meal

    Arm Description

    All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group. The intervention of group one is that participants will be provided with rice-richen meal, meaning most of the calculated carbohydrates are from rice.

    All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group.The intervention of group two is that participants will be provided with wheaten-richen meal, meaning most of the calculated carbohydrates are from wheaten.

    Outcomes

    Primary Outcome Measures

    between-group difference in glucose control
    comparison of the percentage of desired glucose status between two groups

    Secondary Outcome Measures

    between-group difference in undesirable clinical outcome
    comparison of incidence of macrosomia, dystocia, etc.

    Full Information

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

    Unique Protocol Identification Number
    NCT03550963
    Brief Title
    Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)
    Official Title
    Research on Comparison Between Rice-richen Meal and Wheaten-richen Meal on Glucose Control Status Among Chinese Women With GDM
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 23, 2018 (Anticipated)
    Primary Completion Date
    November 23, 2018 (Anticipated)
    Study Completion Date
    February 23, 2019 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Since the prevalence of gestational diabetes melitus (GDM) increased by ..., as an important part of medical treatment, nutrition therapy is highly required to help patients achieve normoglycemia. Carbohydrate intake is the primary nutrient affecting postprandial glucose levels,therefore the total amount and type of carbohydrate should be manipulated to blunt postprandial hyperglycemia. However,the type of carbohydrate has not yet been established. Rice and wheaten food have similar Glycemic Index (GI),but some researches found the glucose response to them is different. A case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    All participants included in the study will be randomized assigned into one of two groups in parallel. Group one will be provided with rice-richen meal, while group two will be provided with wheaten-richen meal. All other factors, i.e. nutrition education, following-up, and physical activity will be the same between two groups.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    rice-richen meal
    Arm Type
    Other
    Arm Description
    All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group. The intervention of group one is that participants will be provided with rice-richen meal, meaning most of the calculated carbohydrates are from rice.
    Arm Title
    wheaten-richen meal
    Arm Type
    Other
    Arm Description
    All participants included in the study will be randomized assigned into one of two groups in parallel, the rice-richen meal group and wheaten-richen meal group.The intervention of group two is that participants will be provided with wheaten-richen meal, meaning most of the calculated carbohydrates are from wheaten.
    Intervention Type
    Other
    Intervention Name(s)
    rice-richen meal
    Intervention Description
    Participants in group one will be provided with rice-richen meal. All participants will be required to test and record blood glucose.
    Intervention Type
    Other
    Intervention Name(s)
    wheaten-richen meal
    Intervention Description
    Participants in group two will be provided with wheaten-richen meal.All participants will be required to test and record blood glucose.
    Primary Outcome Measure Information:
    Title
    between-group difference in glucose control
    Description
    comparison of the percentage of desired glucose status between two groups
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    between-group difference in undesirable clinical outcome
    Description
    comparison of incidence of macrosomia, dystocia, etc.
    Time Frame
    20 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Study participants will be recruited from pregnant women who undergo health examination in Peking Union Medical College Hospital and meet the inclusion criteria.
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant women who undergo health examination in obstetric department in Peking Union Medical College Hospital. 20-45 years old. Pregnant women who are diagnosed with GDM according to the American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria during 24-28 weeks. Be ability to use mobile medical equipment, conditional follow-up of the mother and child. Voluntary participation in this study. Exclusion Criteria: Multiple pregnancy. Merger of serious diseases (such as hypertension, respiratory diseases, kidney disease, abnormal coagulation, immune system diseases, infectious diseases), history of adverse pregnancy (such as spontaneous abortion, habitual abortion), and history of GDM. Pregnant women with known diabetes before pregnancy, those requiring insulin or hormone therapy. Pregnant women who are deemed inappropriate to participate in this clinical study by her physician.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanping Liu, master
    Phone
    +861069159081
    Email
    liuyp1227@vip.sina.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang Wang, master
    Phone
    +8615201646084
    Email
    yours.fang@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanping Liu, master
    Organizational Affiliation
    Peking Union Medical College Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Rice-richen and Wheaten-richen Meal on Glucose Control Among Chinese Women With Gestational Diabetes Melitus (GDM)

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