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.
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
- Conditions the study is for
- Gestational Diabetes Mellitus, Pregnancy Outcome, Neurodevelopment
- 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.
Songying Shen, MSc contact
China1 site, 1 recruiting
- 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
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.
- Conditions
- Gestational Diabetes Mellitus, Pregnancy Outcome, Neurodevelopment, Immune Development, Childhood Obesity, Host and Microbiome
- 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.
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)
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
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
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
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
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.
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.
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.
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.
- First posted28 Aug 2020
- Study start1 Feb 2012
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Qiu, Guangzhou Women and Children's Medical Center
- Investigators
- Xiu Qiu, MD,PhD, Principal investigator, Guangzhou Women and Children's Medical Center, China
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 28321694Shen 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 28122694Shen 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