Clinical trial NCT04529889: GDM and Its Consequences in Mothers and Offsprings
Official title: Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes Mellitus
Pregnancy Outcome
Neurodevelopment
Immune Development
Childhood Obesity
Host and Microbiome
Keywords: Hyperglycaemia
Maternal health
Children
Cohort
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with gestational diabetes mellitus during pregnancy and their offsrpings

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of obesity status during childhood and adolescence
timeFrame: At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
Secondary outcomes:
measure: Number of participants with adverse pregnancy outcomes
timeFrame: At delivery
measure: Change of type 2 diabetes status in mothers
timeFrame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
measure: Change of body composition of mothers
timeFrame: At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery
measure: Change of depression symptom of mothers
timeFrame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
measure: Change of neurodevelopment at early childhood
timeFrame: age of 6 weeks, 6 months, 1 year and 3 years.
measure: Change of lung function during childhood and adolescence
timeFrame: At age of 6 years, 12 years and 18 years.
measure: Change of Allergic diseases status during childhood and adolescence
timeFrame: At age of 1 year, 3 years, 6 years, 12 years and 18 years.
measure: Change of type 2 diabetes during childhood and adolescence
timeFrame: At age of 6 years, 12 years and 18 years.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center, China
name: Xiu Qiu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.