GDM and Its Consequences in Mothers and Offsprings

NCT ID: NCT04529889

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 7000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-01
• Study Completion Date: 2038-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Xiu Qiu

Director of the Born in Guangzhou Cohort Study

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiu Qiu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center, China

Locations

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiu Qiu, MD,PhD

Role: CONTACT

qxiu0161@163.com

0086 20 38367160

Songying Shen, MSc

Role: CONTACT

0086 20 38367159

Facility Contacts

Qiu Qiu, MD,PhD

Role: primary

qxiu0161@163.com

0086 20 38367160

Songying Shen, MSc

Role: backup

0086 20 38367159

References

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.

Reference Type: BACKGROUND

PMID: 28321694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28122694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30619087 (View on PubMed)

Other Identifiers

81803251

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

201943701

Identifier Type: -

Identifier Source: org_study_id