跳至主要内容
临床试验/NCT04550806
NCT04550806Unknown不适用

The Predictive Ability of Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Diagnosis

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Area under the curve of GA combined with body composition for GDM diagnosis

研究概览

简要总结

This study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis.

详细描述

The prevalence of GDM is increasing all over the world. It has bad influence for both pregnant women and fetus. Early treatment is useful for GDM prevention. Therefore early screening is important for healthcare doctors to detect the potential patients. Glycated albumin (GA) is an optimal index for blood glucose evaluation compared to HbA1c, however it may be influenced by body weight and composition. The investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis. This study recruit pregnant women before 12 weeks of their pregnant age and test GA level and body composition via bioelectrical impedance analysis. During 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for GDM diagnosis.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • Age between 20-45
  • Healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease,

排除标准

  • Diabetes that appeared before pregnancy
  • Pregnant with medical disease, such as asthma, hypertension, cardiovascular diseases, kidney diseases or liver disease.
  • Hormone use in the recent 1 year
  • Assisted reproduction pregnancy
  • Multiple births
  • Cannot complete the blood test or body composition examination

结局指标

主要结局

Area under the curve of GA combined with body composition for GDM diagnosis

时间窗: May 2021

prediction ability of GA and body compostion

次要结局

  • correlative factors for GDM(May 2021)
  • GDM prediction model establishment(May 2021)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验