Twins Born in Guangzhou

Childhood Obesity Clinical Trial

— 2-BIG  

Official title:

Twins Born in Guangzhou Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331133
• Other study ID #: 2017060803
• Status: Recruiting
• Start date: February 1, 2012
• Est. completion date: December 31, 2038

Study information

• Verified date: February 2024
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu, PhD
• Phone: 0086 20 38367162
• Email: xiu.qiu[@]bigcs.org/qxiu0161[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The 2-BIG is a twin birth cohort study located in Guangzhou, China.Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental, family and lifestyle exposures on twins from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the twins and their parents.

Description:

Twins share the same intrauterine environment and the early family environment. When conducting research of chronic disease etiology, twins cohort can be a good control of bias from age, gender, genetic and early environment. Twin-based designs provide an estimate of the relative contribution of genetic and non-genetic factors to a specific phenotype. Twins study has an advantage of calculating heritability of traits. Since heritability of traits is various from different populations. It is important to establish database to calculate the heritability of traits associated with chronic major diseases in Chinese population. Twins cohort is rare in China at present. Therefore, extensive information including physical characteristics, mental health, and behaviors is collected from both twins and their parents. Longitudinal follow-up and surveillance of common diseases are also to be conducted. The 2-BIG aims to explore epigenetic markers and genes related to health status, as well as gene-environment interactions on diseases, both in intrauterine and childhood stages, especially in Chinese population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Live twins delivered in Guangzhou Women and Children's Medical Center

2. Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years

3. Baseline information during pregnancy available

Related Conditions & MeSH terms

• Childhood Obesity
• Host and Microbiome
• Immune Development
• Neurodevelopment
• Pediatric Obesity
• Twin Diseases

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

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/s10654-017-02 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopment at early childhood	Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.	At age of 1 year old
Primary	Intelligence quotient	Assessed using the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition including 5 verbal and 3 performance subtests. Intelligence quotient ranges 40-160, in which under 70 is defined as mental retardation. The total score was calculated by an online system.	At age of 6 years old
Primary	Change of gene expression during childhood	DNA methylation, histone acetylation etc. assessed by analyses of blood samples	Age at 1 year , 6 years, 12years and 18years
Secondary	Change of intestinal flora during early childhood	Assessed by analyses of stool samples	Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Secondary	Changes of body composition and bone density during early childhood	Body composition and bone density are assessed using Dual Energy X-Ray Absorptiometry	At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
Secondary	Height in kilometer changes during childhood	Measured by nurses in clinic	At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Secondary	Weight in kilogram changes during childhood	Measured by nurses in clinic	At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year

External Links

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