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Twins Born in Guangzhou (2-BIG)

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ClinicalTrials.gov Identifier: NCT03331133
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Xiu Qiu, Guangzhou Women and Children's Medical Center

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
Twin Diseases Immune Development Childhood Obesity Host and Microbiome Neurodevelopment 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Twins Born in Guangzhou Cohort Study
Actual Study Start Date : February 1, 2012
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2038

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



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
During pregnancy: maternal blood, urine and stool At delivery: cord, cord blood and placenta During Infancy:dry blood spot, stool and blood During childhood: blood, buccal swab and stool


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Twins delivered in Guangzhou, China and their parents
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331133


Contacts
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Contact: Xiu Qiu, PhD 0086 20 38367162 xiu.qiu@bigcs.org/qxiu0161@163.com
Contact: Xuan Zhao, MSc 0086 20 38367159 xuan.zhao@bigcs.org

Locations
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China, Guangdong
Guangzhou Women and Children's Medical Center Recruiting
Guangzhou, Guangdong, China, 510623
Contact: Xiu Qiu, PhD    0086 20 38367162    qxiu0161@163.com   
Sponsors and Collaborators
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: Xiu Qiu, PhD Born in Guangzhou Cohort Study in Guangzhou Women and Children's Medical Center

Additional Information:
Publications of Results:
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Responsible Party: Xiu Qiu, Director of the Born in Guangzhou Cohort Study, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT03331133     History of Changes
Other Study ID Numbers: 2017060803
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiu Qiu, Guangzhou Women and Children's Medical Center:
Twin
Early Development
Cohort
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms