GDM and Its Consequences in Mothers and Offsprings

Recruiting

• Conditions: Immune Development; Pregnancy Outcome; Gestational Diabetes Mellitus; Neurodevelopment; Childhood Obesity; Host and Microbiome

• Registration Number: NCT04529889
• Lead Sponsor: Guangzhou Women and Children's Medical Center

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.

Study Timeline

• Study Start: 2012-02-01
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2038-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

Inclusion Criteria

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

Exclusion Criteria

1. Women with pre-gestational diabetes mellitus
2. Women with chronic hypertension or kidney disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of obesity status during childhood and adolescence	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 Outcome Measures

Name	Time	Method
Change of neurodevelopment at early childhood	age of 6 weeks, 6 months, 1 year and 3 years.	Assessed by Gesell Developmental Schedules and Ages\&Stages Questionnaires which include adaptive, gross motor, fine motor, language, and social function domains. Higher intelligence quotient score in each domain is considered a better outcome. Intelligence quotient of Gesell Developmental Schedules being less than 86 or intelligence quotient of Ages\&Stages Questionnaires being no more than -2SD under the mean is defined as suspected development retardation.
Change of lung function during childhood and adolescence	At age of 6 years, 12 years and 18 years.	Zrs, R5, R20, X5, X20, Fres assessed by impulse oscillometry
Change of depression symptom of mothers	At 1 year, 3 years , 6 years, 12 years and 18 year after delivery	Using Edinburgh Postnatal Depression Scale and Self-rating Depression Scale to assess maternal depression. Higher score is considered more depressive.
Change of Allergic diseases status during childhood and adolescence	At age of 1 year, 3 years, 6 years, 12 years and 18 years.	Eczema, allergic rhinitis, wheeze, and asthma diagnosed by the doctors or assessed by the standardized questionnaires
Change of type 2 diabetes during childhood and adolescence	At age of 6 years, 12 years and 18 years.	Assessed by testing concentrations of children's blood glucose.
Number of participants with adverse pregnancy outcomes	At delivery	Including abortion, stillbirth, live birth, macrosomia, preterm birth, low birth weight, caesarean section delivery, and birth defects.
Change of type 2 diabetes status in mothers	At 1 year, 3 years , 6 years, 12 years and 18 year after delivery	Assessed by testing concentrations of maternal blood glucose.
Change of body composition of mothers	At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery	Assessed body composition using dual-energy X-ray absorptiometry.

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China