Early Diagnosis of GDM by Multiomics

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: Questionnaire survey and specimen collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM group<br>Pregnant women with positive OGTT results at 24-28 gestational weeks | Other: Questionnaire survey and specimen collection<br>* A questionnaire survey was conducted when pregnant women were enrolled in the first trimester, and blood, urine, saliva and other specimens were collected.<br>|
| Control group<br>Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group | Other: Questionnaire survey and specimen collection<br>* A questionnaire survey was conducted when pregnant women were enrolled in the first trimester, and blood, urine, saliva and other specimens were collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) |