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GDM and Its Consequences in Mothers and Offsprings (GDMCMO)

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ClinicalTrials.gov Identifier: NCT04529889
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Xiu Qiu, Guangzhou Women and Children's Medical Center

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Gestational Diabetes Mellitus Pregnancy Outcome Neurodevelopment Immune Development Childhood Obesity Host and Microbiome

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 Design
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Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gestational Diabetes Mellitus and Its Consequences in Mothers and Offsprings
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : December 31, 2038
Estimated Study Completion Date : December 31, 2038

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.


Biospecimen Retention:   Samples With DNA
During pregnancy: maternal blood and urine. At delivery: cord, cord blood and placenta. During infancy: dry blood spot and blood of children. During childhood: blood and buccal swab of children; blood of mothers.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with gestational diabetes mellitus during pregnancy and their offsrpings
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529889


Contacts
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Contact: Xiu Qiu, MD,PhD 0086 20 38367160 qxiu0161@163.com
Contact: Songying Shen, MSc 0086 20 38367159

Locations
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China, Guangdong
Guangzhou Women and Children's Medical Center Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Qiu Qiu, MD,PhD    0086 20 38367160    qxiu0161@163.com   
Contact: Songying Shen, MSc    0086 20 38367159      
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: Xiu Qiu, MD,PhD Guangzhou Women and Children's Medical Center, China
More Information
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Publications:

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Responsible Party: Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT04529889    
Other Study ID Numbers: 201943701
81803251 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiu Qiu, Guangzhou Women and Children's Medical Center:
Hyperglycaemia
Maternal health
Children
Cohort
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight