Early Diagnosis of GDM by Multiomics

Women's Hospital School Of Medicine Zhejiang University

Status: Enrolling

Conditions: Gestational Diabetes Mellitus

Treatments: Other: Questionnaire survey and specimen collection

Study type: Observational

Funder types: Other

Identifiers

NCT05386927

IRB-20210293-R

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

5,000 participants in 2 patient groups

GDM group

Description:

Pregnant women with positive OGTT results at 24-28 gestational weeks

Treatment:

Other: Questionnaire survey and specimen collection

Control group

Description:

Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group

Treatment:

Other: Questionnaire survey and specimen collection