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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05386927
Enrollment
5000
Registered
2022-05-23
Start date
2022-05-01
Completion date
2024-12-31
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus

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.

Interventions

A questionnaire survey was conducted when pregnant women were enrolled in the first trimester, and blood, urine, saliva and other specimens were collected.

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary metabolomicsFirst 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 lipidomicsFirst 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 metabolomicsFirst 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.

Countries

China

Contacts

Primary ContactZhaoxia Liang, Prof.
xiaozaizai@zju.edu.cn86571-89992115

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026