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Gestational Diabetes MellitusGDMCMONCT04529889

GDM and Its Consequences in Mothers and Offsprings

An observational study of Gestational Diabetes Mellitus and Pregnancy Outcome, run by Guangzhou Women and Children's Medical Center at 1 site in China.

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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
7,000 participants
Where
1 siteChina
Study dates
1 Feb 2012to 31 Dec 2038
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Women diagnosed with gestational diabetes mellitus during pregnancy and their offsrpings

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiu Qiu, MD,PhD contact

0086 20 38367160

qxiu0161@163.com

Songying Shen, MSc contact

0086 20 38367159

China1 site, 1 recruiting
  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong, 510623

    Qiu Qiu, MD,PhD, 0086 20 38367160, qxiu0161@163.com

    Songying Shen, MSc, 0086 20 38367159

    Recruiting

Other trials in China

About this study

Official title: Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings

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.

Read the 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.

Keywords
Hyperglycaemia, Maternal health, Children, Cohort
Medical subject headings
Diabetes, Gestational, Pediatric Obesity, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Other

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year

Secondary outcomes (8)
  1. Number of participants with adverse pregnancy outcomes

    Including abortion, stillbirth, live birth, macrosomia, preterm birth, low birth weight, caesarean section delivery, and birth defects.

    Measured: At delivery

  2. Change of type 2 diabetes status in mothers

    Assessed by testing concentrations of maternal blood glucose.

    Measured: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery

  3. Change of body composition of mothers

    Assessed body composition using dual-energy X-ray absorptiometry.

    Measured: At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery

  4. 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.

    Measured: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery

  5. 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.

    Measured: age of 6 weeks, 6 months, 1 year and 3 years.

  6. Change of lung function during childhood and adolescence

    Zrs, R5, R20, X5, X20, Fres assessed by impulse oscillometry

    Measured: At age of 6 years, 12 years and 18 years.

  7. 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

    Measured: At age of 1 year, 3 years, 6 years, 12 years and 18 years.

  8. Change of type 2 diabetes during childhood and adolescence

    Assessed by testing concentrations of children's blood glucose.

    Measured: At age of 6 years, 12 years and 18 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start1 Feb 2012
  3. Primary completion31 Dec 2038 (estimated)
  4. Study completion31 Dec 2038 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04529889
Sponsor's protocol ID
201943701
Other IDs
81803251
Acronym
GDMCMO
Status last verified
Sep 2023
First submitted
20 Jul 2020
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28321694
  • 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.

    PubMed 28122694
  • 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.

    PubMed 30619087

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