Early Diagnosis of GDM by Multiomics

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386927
• Other study ID #: IRB-20210293-R
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Zhaoxia Liang, Prof.
• Phone: 86571-89992115
• Email: xiaozaizai[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• Plan to have routine prenatal examinations and give birth in the research center
• First trimester
• Singleton pregnancy
• Without pregnancy complications
• Willing to cooperate with the hospital to follow up

Exclusion Criteria:

• Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
• Fetus has a known deformity or genetic defects
• Incomplete clinical data

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary metabolomics	The differential salivary metabolism molecules in saliva were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.	First trimester (9-14 gestational weeks)
Primary	Serum lipidomics	The differential serum lipid molecules in serum were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.	First trimester (9-14 gestational weeks)
Primary	Urine metabolomics	The differential urine metabolism molecules in urine were detected by the self-developed detection chip, and the markers related to GDM in early pregnancy were screened. Specimens were collected during the first trimester.	First trimester (9-14 gestational weeks)