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
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
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
NCT ID
NCT02740283
First Posted
April 2, 2016
Last Updated
April 14, 2016
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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
Learn more about this trial
The Early Diagnosis of Gestational Diabetes Mellitus Study
We'll reach out to this number within 24 hrs