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临床试验/NCT03246295
NCT03246295Unknown不适用

Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

Peking Union Medical College Hospital0 个研究点目标入组 140 人开始时间: 2015年10月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
Urinary samples were analyzed

研究概览

简要总结

Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (<12 weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women (<12 weeks)

排除标准

  • with renal dysfunction
  • urine routine examination abnormalities for twice
  • history of urinary and reproductive system diseases
  • with other chronic diseases

结局指标

主要结局

Urinary samples were analyzed

时间窗: in the first (<12 weeks) trimester of pregnancy

Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.

次要结局

  • Urinary samples were analyzed(in the third (>32 weeks) trimester of pregnancy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

wuxueyan

professor,MD

Peking Union Medical College Hospital

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