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临床试验/NCT04529889
NCT04529889招募中不适用

Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
7,000
试验地点
1
主要终点
Change of obesity status during childhood and adolescence

研究概览

简要总结

Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term consequences for both mother and child. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery.

详细描述

Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term consequences for both mother and child. Although maternal hyperglycemia often become normal shortly after pregnancy, women with GDM have crucially increased risk of development of type 2 diabetes later in life and the mechanisms are not fully understand. Systematic follow-up of the outcomes related to GDM would be ideal to observe the nature progression of GDM to diabetes and could help to develop preventable targets for intervention. The risks of obesity, the metabolic syndrome, and type 2 diabetes in offspring of mothers with GDM significantly increased 1-7 folds than those whose mothers didn't have GDM. The underlying pathogenic mechanisms behind the impaired metabolic risk profile and other diseases in offspring are unknown, but environmental changes including epigenetic changes induced by exposure to maternal hyperglycaemia and genetic factors may play essential roles. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery. We also aim to identify the high-risk population of mother-child pairs who are more likely to develop these adverse consequences, which might help to improve precise intervention and resource saving and provide evidence for preventable targets development.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnant women diagnosed with gestational diabetes mellitus
  • Pregnant women intended to eventually deliver in Guangzhou Women and Children's Medical Center
  • Permanent residents or families intended to remain in Guangzhou with their child for no less than 3 years

排除标准

  • Women with pre-gestational diabetes mellitus
  • Women with chronic hypertension or kidney disease

结局指标

主要结局

Change of obesity status during childhood and adolescence

时间窗: At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year

Weight in kilograms and height in meters were measured by nurses in clinic using standard tools. Weight and height will be combined to report BMI in kg/m\^2. Childhood obesity is defined as a BMI equal to or larger than the 95th percentile for age by sex based on WHO Child Growth Standards.

次要结局

  • Change of depression symptom of mothers(At 1 year, 3 years , 6 years, 12 years and 18 year after delivery)
  • Change of Allergic diseases status during childhood and adolescence(At age of 1 year, 3 years, 6 years, 12 years and 18 years.)
  • Change of type 2 diabetes during childhood and adolescence(At age of 6 years, 12 years and 18 years.)
  • Number of participants with adverse pregnancy outcomes(At delivery)
  • Change of type 2 diabetes status in mothers(At 1 year, 3 years , 6 years, 12 years and 18 year after delivery)
  • Change of body composition of mothers(At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery)
  • Change of neurodevelopment at early childhood(age of 6 weeks, 6 months, 1 year and 3 years.)
  • Change of lung function during childhood and adolescence(At age of 6 years, 12 years and 18 years.)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

研究点 (1)

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