Study on Early Screening Biomarkers of Gestational Diabetes Mellitus and Its Related Pathogenesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Significantly different metabolites at 16-18 gestational weeks
研究概览
简要总结
Gestational Diabetes Mellitus (GDM) refers to the abnormal glucose metabolism first detected during pregnancy. It is estimated that approximately 7% of pregnant women worldwide and their offspring are affected by GDM. The incidence of GDM in China is as high as 18.9%. A number of studies have shown that GDM complicates 3%-25% of pregnancies and poses serious health and life threats to the mother and child. In fact, due to the lack of physical activity during pregnancy and the decrease of insulin sensitivity compared with non-pregnancy, the optimal time for intervention has long been lost until the diagnosis of GDM in the second trimester. However, it is a pity that no authoritative screening method for GDM in early pregnancy has been established, and the pathogenesis of GDM is still unclear. This study intend to search for biomarkers used for screening of GDM in early pregnancy and explore the pathogenesis of GDM, so as to provide new ideas for prevention measures and treatment targets of GDM.
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
- •Maternal age: 20-49 years
- •Plan to have routine prenatal examinations and give birth in the research center
- •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, hypertension, heart disease, liver and kidney diseases, thyroid diseases, 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
Significantly different metabolites at 16-18 gestational weeks
时间窗: Gestatioanl weeks: 16-18 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different metabolites at 32-34 gestational weeks
时间窗: Gestatioanl weeks: 32-34 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different proteins at 16-18 gestational weeks
时间窗: Gestatioanl weeks: 16-18 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different metabolites at 8-10 gestational weeks
时间窗: Gestatioanl weeks: 8-10 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different metabolites at 24-26 gestational weeks
时间窗: Gestatioanl weeks: 24-26 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different proteins at 32-34 gestational weeks
时间窗: Gestatioanl weeks: 32-34 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different proteins at 8-10 gestational weeks
时间窗: Gestatioanl weeks: 8-10 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Significantly different proteins at 24-26 gestational weeks
时间窗: Gestatioanl weeks: 24-26 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
次要结局
未报告次要终点