Skip to main content
Clinical Trials/NCT04529889
NCT04529889
Recruiting
Not Applicable

Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings

Guangzhou Women and Children's Medical Center1 site in 1 country7,000 target enrollmentFebruary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes Mellitus
Sponsor
Guangzhou Women and Children's Medical Center
Enrollment
7000
Locations
1
Primary Endpoint
Change of obesity status during childhood and adolescence
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2012
End Date
December 31, 2038
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guangzhou Women and Children's Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Guangzhou Women and Children's Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change of obesity status during childhood and adolescence

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (1)

Loading locations...

Similar Trials