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The Early Diagnosis of Gestational Diabetes Mellitus Study (EDoGDM)

Primary Purpose

Gestational Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
glycemic monitoring
dietary guide
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes Mellitus focused on measuring Gestational Diabetes Mellitus, Oral Glucose Tolerance Test

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Singleton pregnant women will be invited to participate in this study if they are between 18 and 40 years of age, and have had their first prenatal visit in our center before 18 weeks 0 days of gestation.

Exclusion Criteria:

  • Previous history of GDM or preexisting DM
  • Family history of diabetes mellitus (first degree relative with diabetes or a sister with GDM)
  • Body mass index>30 kg/m2
  • Previous macrosomia (baby with birth weight >4,000 g) or a history of stillbirth
  • Polycystic ovary syndrome
  • Medications: corticosteroids, antipsychotics
  • Participant not willing to take OGTT twice (at 18-20 gestational weeks and 24-28 gestational weeks), or not willing to have a series of prenatal care visits and deliver in our center.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pregnant women

    Arm Description

    As a diagnostic study, the cohort will recruit 300 pregnant women who meet inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early-OGTT) and 24 to 28 gestational weeks (regular-OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis.

    Outcomes

    Primary Outcome Measures

    Rate of GDM diagnosed in 18-20 gestational week.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2016
    Last Updated
    April 14, 2016
    Sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02740283
    Brief Title
    The Early Diagnosis of Gestational Diabetes Mellitus Study
    Acronym
    EDoGDM
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    5. Study Description

    Brief Summary
    The main purpose of the study is to evaluate an OGTT at 18 to 20 gestational weeks as an early diagnosis method of GDM in low risk pregnant women. By investigating maternal and neonatal outcomes that are associated with the early OGTT and regular OGTT results, the study will provide a evidence for the most appropriate time to perform an OGTT in pregnant women.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus
    Keywords
    Gestational Diabetes Mellitus, Oral Glucose Tolerance Test

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregnant women
    Arm Type
    Experimental
    Arm Description
    As a diagnostic study, the cohort will recruit 300 pregnant women who meet inclusion and exclusion criteria outlined below. OGTTs will be performed between 18 and 20 gestational weeks (early-OGTT) and 24 to 28 gestational weeks (regular-OGTT). Clinical and laboratory information of the mother and their offspring will be collected for analysis.
    Intervention Type
    Behavioral
    Intervention Name(s)
    glycemic monitoring
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    dietary guide
    Primary Outcome Measure Information:
    Title
    Rate of GDM diagnosed in 18-20 gestational week.
    Time Frame
    up to 12 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Singleton pregnant women will be invited to participate in this study if they are between 18 and 40 years of age, and have had their first prenatal visit in our center before 18 weeks 0 days of gestation. Exclusion Criteria: Previous history of GDM or preexisting DM Family history of diabetes mellitus (first degree relative with diabetes or a sister with GDM) Body mass index>30 kg/m2 Previous macrosomia (baby with birth weight >4,000 g) or a history of stillbirth Polycystic ovary syndrome Medications: corticosteroids, antipsychotics Participant not willing to take OGTT twice (at 18-20 gestational weeks and 24-28 gestational weeks), or not willing to have a series of prenatal care visits and deliver in our center.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bin Liu, MD, PhD
    Phone
    +8613570381528
    Email
    robin520666@163.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32898218
    Citation
    Liu B, Cai J, Xu Y, Long Y, Deng L, Lin S, Zhang J, Yang J, Zhong L, Luo Y, Zhou Y, Zhang Y, Li Z, Chen H, Wang Z. Early Diagnosed Gestational Diabetes Mellitus Is Associated With Adverse Pregnancy Outcomes: A Prospective Cohort Study. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa633. doi: 10.1210/clinem/dgaa633.
    Results Reference
    derived
    PubMed Identifier
    27872115
    Citation
    Liu B, Xu Y, Zhang Y, Cai J, Deng L, Yang J, Zhou Y, Long Y, Zhang J, Wang Z. Early Diagnosis of Gestational Diabetes Mellitus (EDoGDM) study: a protocol for a prospective, longitudinal cohort study. BMJ Open. 2016 Nov 21;6(11):e012315. doi: 10.1136/bmjopen-2016-012315.
    Results Reference
    derived

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    The Early Diagnosis of Gestational Diabetes Mellitus Study

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