The Early Diagnosis of Gestational Diabetes Mellitus Study

Gestational Diabetes Mellitus Clinical Trial

— EDoGDM  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02740283
• Other study ID #: SYSU5010-2016014
• Status: Not yet recruiting
• Phase: N/A
• First received: April 2, 2016
• Last updated: April 14, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Bin Liu, MD, PhD
• Phone: +8613570381528
• Email: robin520666[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• glycemic monitoring

Dietary Supplement:
• dietary guide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of GDM diagnosed in 18-20 gestational week.		up to 12 months	Yes