Twins Born in Guangzhou (2-BIG)

February 22, 2024 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center

Twins Born in Guangzhou Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Twins delivered in Guangzhou, China and their parents

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At age of 1 year old
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.
At age of 6 years old
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
Age at 1 year , 6 years, 12years and 18years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Age at 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
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
At birth, age of 6 weeks, 6 months, 1 year , 3 years,6 years, 12years and 18years
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
At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year
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
At birth, age of 6 weeks, 6 months, 1 year, 3 years,6 years, 12years and 18year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017060803

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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