Childhood Obesity Clinical Trial
— GDMCMOOfficial 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.
Status | Recruiting |
Enrollment | 7000 |
Est. completion date | December 31, 2038 |
Est. primary completion date | December 31, 2038 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Guangzhou Women and Children's Medical Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Women and Children's Medical Center |
China,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At age of 6 months, 1 year, 3 years, 6 years, 12 years and 18 year | |
Secondary | Number of participants with adverse pregnancy outcomes | Including abortion, stillbirth, live birth, macrosomia, preterm birth, low birth weight, caesarean section delivery, and birth defects. | At delivery | |
Secondary | Change of type 2 diabetes status in mothers | Assessed by testing concentrations of maternal blood glucose. | At 1 year, 3 years , 6 years, 12 years and 18 year after delivery | |
Secondary | Change of body composition of mothers | 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 | |
Secondary | 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. | At 1 year, 3 years , 6 years, 12 years and 18 year after delivery | |
Secondary | 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. | age of 6 weeks, 6 months, 1 year and 3 years. | |
Secondary | Change of lung function during childhood and adolescence | Zrs, R5, R20, X5, X20, Fres assessed by impulse oscillometry | At age of 6 years, 12 years and 18 years. | |
Secondary | 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 | At age of 1 year, 3 years, 6 years, 12 years and 18 years. | |
Secondary | Change of type 2 diabetes during childhood and adolescence | Assessed by testing concentrations of children's blood glucose. | At age of 6 years, 12 years and 18 years. |
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