Early Diagnosis of GDM by Multiomics

NCT ID: NCT05386927

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-12-31

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

GDM group

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

Questionnaire survey and specimen collection

Intervention Type: OTHER

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

Control group

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

Questionnaire survey and specimen collection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaoxia Liang, Prof.

Role: STUDY_DIRECTOR

Women's Hospital School Of Medicine Zhejiang University

Locations

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaoxia Liang, Prof.

Role: CONTACT

xiaozaizai@zju.edu.cn

86571-89992115

Facility Contacts

Zhaoxia Liang, Prof.

Role: primary

xiaozaizai@zju.edu.cn

86571-89992115

Other Identifiers

IRB-20210293-R

Identifier Type: -

Identifier Source: org_study_id