GDM and Its Consequences in Mothers and Offsprings

NCT04529889 | Recruiting

• 2 other identifiers: 20194370181803251
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus; Pregnancy Outcome; Neurodevelopment; Immune Development; Childhood Obesity; Host and Microbiome

Keywords

Hyperglycaemia; Maternal health; Children; Cohort

Outcome Measures

Primary Outcomes (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.

  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

  At delivery

• Change of type 2 diabetes status in mothers

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

• Change of body composition of mothers

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

• Change of depression symptom of mothers

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

• Change of neurodevelopment at early childhood

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with gestational diabetes mellitus during pregnancy and their offsrpings

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 28321694 BACKGROUND

• 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.

  PMID: 28122694 BACKGROUND

• 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.

  PMID: 30619087 BACKGROUND

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.

MeSH Terms

Conditions

Diabetes, Gestational; Pediatric Obesity; Hyperglycemia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiu Qiu, MD,PhD

  Guangzhou Women and Children's Medical Center, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiu Qiu, MD,PhD

CONTACT

0086 20 38367160; qxiu0161@163.com

Songying Shen, MSc

CONTACT

0086 20 38367159

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Born in Guangzhou Cohort Study

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 28, 2020
• Study Start: February 1, 2012
• Primary Completion (Estimated): December 31, 2038
• Study Completion (Estimated): December 31, 2038
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)