GDM and Its Consequences in Mothers and Offsprings

Childhood Obesity Clinical Trial

— GDMCMO  

Official title:

Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529889
• Other study ID #: 201943701
• Secondary ID: 81803251
• Status: Recruiting
• Start date: February 1, 2012
• Est. completion date: December 31, 2038

Study information

• Verified date: September 2023
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu, MD,PhD
• Phone: 0086 20 38367160
• Email: qxiu0161[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Host and Microbiome
• Immune Development
• Neurodevelopment
• Pediatric Obesity
• Pregnancy Outcome

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (3)

Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20. — View Citation

Shen S, Lu J, Zhang L, He J, Li W, Chen N, Wen X, Xiao W, Yuan M, Qiu L, Cheng KK, Xia H, Mol BWJ, Qiu X. Single Fasting Plasma Glucose Versus 75-g Oral Glucose-Tolerance Test in Prediction of Adverse Perinatal Outcomes: A Cohort Study. EBioMedicine. 2017 Feb;16:284-291. doi: 10.1016/j.ebiom.2017.01.025. Epub 2017 Jan 18. — View Citation

Shen SY, Zhang LF, He JR, Lu JH, Chen NN, Xiao WQ, Yuan MY, Xia HM, Lam KBH, Qiu X. Association Between Maternal Hyperglycemia and Composite Maternal-Birth Outcomes. Front Endocrinol (Lausanne). 2018 Dec 11;9:755. doi: 10.3389/fendo.2018.00755. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of obesity status during childhood and adolescence	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.	At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
Secondary	Number of participants with adverse pregnancy outcomes	Including abortion, stillbirth, live birth, macrosomia, preterm birth, low birth weight, caesarean section delivery, and birth defects.	At delivery
Secondary	Change of type 2 diabetes status in mothers	Assessed by testing concentrations of maternal blood glucose.	At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
Secondary	Change of body composition of mothers	Assessed body composition using dual-energy X-ray absorptiometry.	At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery
Secondary	Change of depression symptom of mothers	Using Edinburgh Postnatal Depression Scale and Self-rating Depression Scale to assess maternal depression. Higher score is considered more depressive.	At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
Secondary	Change of neurodevelopment at early childhood	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.	age of 6 weeks, 6 months, 1 year and 3 years.
Secondary	Change of lung function during childhood and adolescence	Zrs, R5, R20, X5, X20, Fres assessed by impulse oscillometry	At age of 6 years, 12 years and 18 years.
Secondary	Change of Allergic diseases status during childhood and adolescence	Eczema, allergic rhinitis, wheeze, and asthma diagnosed by the doctors or assessed by the standardized questionnaires	At age of 1 year, 3 years, 6 years, 12 years and 18 years.
Secondary	Change of type 2 diabetes during childhood and adolescence	Assessed by testing concentrations of children's blood glucose.	At age of 6 years, 12 years and 18 years.