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Trial record 1 of 1 for:    NCT02740283
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The Early Diagnosis of Gestational Diabetes Mellitus Study (EDoGDM)

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ClinicalTrials.gov Identifier: NCT02740283
Recruitment Status : Unknown
Verified April 2016 by Bin Liu, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Bin Liu, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: glycemic monitoring Dietary Supplement: dietary guide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: glycemic monitoring
Dietary Supplement: dietary guide



Primary Outcome Measures :
  1. Rate of GDM diagnosed in 18-20 gestational week. [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740283


Contacts
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Contact: Bin Liu, MD, PhD +8613570381528 robin520666@163.com

Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bin Liu, Dr., First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02740283    
Other Study ID Numbers: SYSU5010-2016014
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Bin Liu, First Affiliated Hospital, Sun Yat-Sen University:
Gestational Diabetes Mellitus
Oral Glucose Tolerance Test
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications