NCT05386927

Early Diagnosis of GDM by Multiomics

Clinical Study of a New Technology System for Early Diagnosis and Screening of GDM Based on Multiomics

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Gestational diabetes mellitus (GDM) is prone to cause a variety of adverse pregnancy outcomes, and has potential harm to the short-term and long-term health of both mothers and infants. However, its diagnosis mainly relies on oral glucose tolerance test (OGTT) at 24-28 weeks of gestation, so it is often diagnosed in the second and third trimester, and may be too late to intervene. Therefore, advancing the diagnostic window period of GDM is the key to the prevention and treatment of GDM and its complications. It is urgent to establish a new technology for the early diagnosis and screening of GDM with high detection rate and accuracy. Based on literature survey and previous studies, this study found that the combined analysis of metabolomics and lipidomics may have broad clinical application prospects in the early diagnosis and screening of GDM. It is hoped that a set of new techniques based on multi-omics for early diagnosis and screening of GDM can be constructed, providing a feasible and effective tool for early detection and treatment of GDM in clinical.

Conditions

• Gestational Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Questionnaire survey and specimen collection	A questionnaire survey was conducted when pregnant women were enrolled in the first trimester, and blood, urine, saliva and other specimens were collected.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-05-23
• Last updated: 2023-10-19

Locations

1 site across 1 country: China