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2-BIG: Twins Born in Guangzhou

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03331133
Collaborator
(none)
1,000
Enrollment
1
Location
323
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Twins Born in Guangzhou Cohort Study
Actual Study Start Date :
Feb 1, 2012
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2038

Arms and Interventions

Arm Intervention/Treatment
Identical Twins

Twins develop from one zygote with no intervention

Other: No intervention
Dizygotic Twins

Twins develop from two different zygote with no intervention

Other: No intervention

Outcome Measures

Primary Outcome Measures

  1. Neurodevelopment at early childhood [At age of 1 year old]

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

  2. Intelligence quotient [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 [Age at 1 year , 6 years, 12years and 18years]

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

Secondary Outcome Measures

  1. Change of intestinal flora during early childhood [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 [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 [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 [At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year]

    Measured by nurses in clinic

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangzhou Women and Children's Medical Center Guangzhou Guangdong China 510623

Sponsors and Collaborators

  • Guangzhou Women and Children's Medical Center

Investigators

  • Principal Investigator: Xiu Qiu, PhD, Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier:
NCT03331133
Other Study ID Numbers:
  • 2017060803
First Posted:
Nov 6, 2017
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
Twin
Early Development
Cohort
Additional relevant MeSH terms:
Pediatric Obesity

Study Results

No Results Posted as of Mar 22, 2022