The Early Diagnosis of Gestational Diabetes Mellitus Study

NCT ID: NCT02740283

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pregnant women

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.

Group Type: EXPERIMENTAL

glycemic monitoring

Intervention Type: BEHAVIORAL

dietary guide

Intervention Type: DIETARY_SUPPLEMENT

Interventions

glycemic monitoring

Intervention Type: BEHAVIORAL

dietary guide

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Bin Liu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Bin Liu, MD, PhD

Role: CONTACT

robin520666@163.com

+8613570381528

References

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.

Reference Type: DERIVED

PMID: 32898218 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27872115 (View on PubMed)

Other Identifiers

SYSU5010-2016014

Identifier Type: -

Identifier Source: org_study_id