The Early Diagnosis of Gestational Diabetes Mellitus Study

NCT02740283 | Unknown

• 1 other identifier: SYSU5010-2016014
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

Gestational Diabetes Mellitus; Oral Glucose Tolerance Test

Outcome Measures

Primary Outcomes (1)

• Rate of GDM diagnosed in 18-20 gestational week.

  up to 12 months

Study Arms (1)

Pregnant women

EXPERIMENTAL

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.

Behavioral: glycemic monitoring; Dietary Supplement: dietary guide

Interventions

glycemic monitoring BEHAVIORAL

Pregnant women

dietary guide DIETARY_SUPPLEMENT

Pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (2)

• 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.

  PMID: 32898218 DERIVED

• 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.

  PMID: 27872115 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Bin Liu, MD, PhD

CONTACT

+8613570381528; robin520666@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: April 15, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 15, 2016

Record last verified: 2016-04