- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529889
GDM and Its Consequences in Mothers and Offsprings (GDMCMO)
September 11, 2023 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
7000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Songying Shen, MSc
- Phone Number: 0086 20 38367159
Study Contact Backup
- Name: Xiu Qiu, MD,PhD
- Phone Number: 0086 20 38367160
- Email: qxiu0161@163.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510623
- Recruiting
- Guangzhou Women And Children's Medical Center
-
Contact:
- Songying Shen, MSc
- Phone Number: 0086 20 38367159
-
Contact:
- Qiu Qiu, MD,PhD
- Phone Number: 0086 20 38367160
- Email: qxiu0161@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Women diagnosed with gestational diabetes mellitus during pregnancy and their offsrpings
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Women with pre-gestational diabetes mellitus
- Women with chronic hypertension or kidney disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of obesity status during childhood and adolescence
Time Frame: At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse pregnancy outcomes
Time Frame: At delivery
|
Including abortion, stillbirth, live birth, macrosomia, preterm birth, low birth weight, caesarean section delivery, and birth defects.
|
At delivery
|
Change of type 2 diabetes status in mothers
Time Frame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
|
Assessed by testing concentrations of maternal blood glucose.
|
At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
|
Change of body composition of mothers
Time Frame: At 42 days, 6 months, 1 year, 3 years , 6 years, 12 years and 18 year after delivery
|
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
|
Change of depression symptom of mothers
Time Frame: At 1 year, 3 years , 6 years, 12 years and 18 year after delivery
|
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
|
Change of neurodevelopment at early childhood
Time Frame: age of 6 weeks, 6 months, 1 year and 3 years.
|
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.
|
Change of lung function during childhood and adolescence
Time Frame: At age of 6 years, 12 years and 18 years.
|
Zrs, R5, R20, X5, X20, Fres assessed by impulse oscillometry
|
At age of 6 years, 12 years and 18 years.
|
Change of Allergic diseases status during childhood and adolescence
Time Frame: At age of 1 year, 3 years, 6 years, 12 years and 18 years.
|
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.
|
Change of type 2 diabetes during childhood and adolescence
Time Frame: At age of 6 years, 12 years and 18 years.
|
Assessed by testing concentrations of children's blood glucose.
|
At age of 6 years, 12 years and 18 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiu Qiu, MD,PhD, Guangzhou Women and Children's Medical Center, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2012
Primary Completion (Estimated)
December 31, 2038
Study Completion (Estimated)
December 31, 2038
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201943701
- 81803251 (Other Grant/Funding Number: National Natural Science Foundation of China)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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