Clinical trial NCT03331133: Twins Born in Guangzhou
Official title: Twins Born in Guangzhou Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Twin Diseases
Immune Development
Childhood Obesity
Host and Microbiome
Neurodevelopment
Keywords: Twin
Early Development
Cohort
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twins delivered in Guangzhou, China and their parents

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurodevelopment at early childhood
timeFrame: At age of 1 year old
measure: Intelligence quotient
timeFrame: At age of 6 years old
measure: Change of gene expression during childhood
timeFrame: Age at 1 year , 6 years, 12years and 18years
Secondary outcomes:
measure: Change of intestinal flora during early childhood
timeFrame: Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
measure: Changes of body composition and bone density during early childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
measure: Height in kilometer changes during childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
measure: Weight in kilogram changes during childhood
timeFrame: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center
name: Xiu Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.