Clinical Study of a New Technology System for Early Diagnosis and Screening of GDM Based on Multiomics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Salivary metabolomics
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Salivary metabolomics
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点