Early Diagnosis of GDM by Multiomics

Recruiting

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Questionnaire survey and specimen collection

• Registration Number: NCT05386927
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-15
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM group	Questionnaire survey and specimen collection	Pregnant women with positive OGTT results at 24-28 gestational weeks
Control group	Questionnaire survey and specimen collection	Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group

Primary Outcome Measures

Name	Time	Method
Salivary metabolomics	First trimester (9-14 gestational weeks)	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.
Serum lipidomics	First trimester (9-14 gestational weeks)	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.
Urine metabolomics	First trimester (9-14 gestational weeks)	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.

Trial Locations

Locations (1)

Women's Hospital School Of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China