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NCT Number: NCT03331133

Twins Born in Guangzhou

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.

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Key information

Conditions

Twin Diseases Body Weight Childhood Obesity Disease Attributes Diseases in Twins Host and Microbiome Immune Development Neurodevelopment Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location status: Recruiting

Location contact

Xiu Qiu, PhD

CONTACT

[email protected]

0086 20 38367162

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Live twins delivered in Guangzhou Women and Children's Medical Center
  • Permanent residents or families intended to remain in Guangzhou with their children for no less than 3 years
  • Baseline information during pregnancy available

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Neurodevelopment at early childhood

    Time frame: At age of 1 year old

    Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.

  2. Intelligence quotient

    Time frame: At age of 6 years old

    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.

  3. Change of gene expression during childhood

    Time frame: Age at 1 year , 6 years, 12years and 18years

    DNA methylation, histone acetylation etc. assessed by analyses of blood samples

Secondary outcomes

  1. Change of intestinal flora during early childhood

    Time frame: Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years

    Assessed by analyses of stool samples

  2. Changes of body composition and bone density during early childhood

    Time frame: At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years

    Body composition and bone density are assessed using Dual Energy X-Ray Absorptiometry

  3. Height in kilometer changes during childhood

    Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year

    Measured by nurses in clinic

  4. Weight in kilogram changes during childhood

    Time frame: At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year

    Measured by nurses in clinic

Study contacts

Contact information is provided by the study sponsor or research team.

Xiu Qiu, PhD

CONTACT

[email protected]/[email protected]

0086 20 38367162

Xuan Zhao, MSc

CONTACT

[email protected]

0086 20 38367159

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Registry information

Official study title

Twins Born in Guangzhou Cohort Study

Acronym: 2-BIG

Important dates

Study start
2012
Primary completion
2025
Study completion
2038
First posted
Nov 6, 2017
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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