GUSTO: Growing Up in Singapore Towards Healthy Outcomes

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01174875
Collaborator
KK Women's and Children's Hospital (Other), Singapore Institute for Clinical Sciences (Other)
1,247
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241
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Study Details

Study Description

Brief Summary

This study aims to test the following hypotheses in women recruited in early pregnancy and whose children will be followed up till at least 14 years of age.

  • Epigenetic changes in conceptual tissues obtained at birth reflect the environment that the fetus was exposed to during development.

  • The pattern of epigenetic marks in gene promoters obtained from DNA in birth tissues, together with genotype, phenotype, and environmental exposures, can be utilized to assess how the perinatal environment affects subsequent metabolic, neurodevelopmental and other phenotypes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The dramatic emergence of non-communicable diseases (NCDs) in Asia has coincided with the rapid socioeconomic and nutritional transition taking place in the region, with the prevalence of diabetes rising five-fold in Singapore in less than four decades. One unique aspect of the epidemic has been the significant ethnic differences in predisposition to diabetes among Asians and in the ethnic variation between BMI and the risk of developing insulin resistance, a precursor to type 2 diabetes. Apart from genetic factors, dietary, lifestyle and cultural factors might have influenced the developmental programming through effects on the mechanisms associated with developmental plasticity. A center piece of this study is to examine how epigenetic changes at birth both reflects past developmental influences and, in association with other factors, influences future trajectories of development and its relationship to NCDs. Also factors active during childhood - especially the first 1000 days of life - will be focused upon.

    The longitudinal GUSTO birth cohort study allows us to examine associations among genetic, environmental and lifestyle interactions in the three distinct ethnic groups, Chinese, Malays and Indians, present in the Singaporean population.

    Participants have been followed up for their pregnancy outcome, fetal growth and offspring development right up to age 11 currently. Participants will continue to be followed up as the children enter into the pubertal phase from the age of 10 to 14 years.

    Data will be collected through questionnaires and clinical measurements. The questionnaires include socio-economic factors, maternal and child's diet, medical histories, behavioural, cognition, lifestyle factors, health status, and home environment. Bio-physical measurements will be obtained from anthropometric measurements of participants, human biological materials such as blood, buccal swabs, saliva, hair, urine, stool, oral specimen such as exfoliated milk teeth, dental plaque and tongue biofilms are collected from the participants (mother / father / child where applicable) at their follow-up time points with the GUSTO cohort upon their consent.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1247 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Metabolic Health in Asian Women and Their Children
    Actual Study Start Date :
    Jun 1, 2009
    Anticipated Primary Completion Date :
    Jul 1, 2029
    Anticipated Study Completion Date :
    Jul 1, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Pregnant mothers, infants and children

    Women in their early pregnancy who are attending the first trimester antenatal ultrasound scan at the public maternity units at KK Women's and Children's Hospital (KKH) and National University Hospital (NUH). Only women age 18 years and above who are Singapore Citizens or Singapore Permanent Residents. Participants have to intend to eventually deliver in NUH or KKH and to reside in Singapore for the next 5 years. Willingness to donate cord, cord blood and placenta. The fetus should be racially homogenous with both sets of grandparents of the same ethnicity. Babies born from these mothers will be followed up until the child is at least 14 years of age.

    Outcome Measures

    Primary Outcome Measures

    1. Roles of fetal, developmental and epigenetic factors in pathways to disease [Perinatal]

      To evaluate the role of fixed genetic risk variants, modifiable epigenetic markers, circulating metabolites and hormones in blood, and host-microbe interactions which can reflect past developmental influences, and in association with other factors, affect future trajectories of development and its relationship to NCDs.

    Secondary Outcome Measures

    1. Influence of prenatal and early postnatal factors on child health [During pregnancy and infancy period]

      To examine the role of maternal nutrition, lifestyle, emotional health, and other environmental factors in infancy that can influence the development of phenotypes in childhood which confer risk for later metabolic and mental disorders.

    2. Effect of factors in pregnancy and early postpartum period on maternal health [During pregnancy and postpartum period]

      To examine the role of maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of metabolic disorders, including body weight changes.

    3. Influence genetic and epigenetics factors in combination with lifestyle on child health [Childhood and Adolescence up to age 14]

      To examine the role of genetic and epigenetic factors, lifestyle (physical activity and dietary intake), growth trajectories and other environmental factors that can influence the development of phenotypes in childhood which confer risk for later metabolic and mental disorders.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women 18 years and above

    • Pregnant women attending the first visit (< 14 weeks GA) at the maternity units of KKH and NUH

    • Singapore citizens or Singapore Permanent Residents

    • Currently resident in mainland Singapore

    • Intention to eventually deliver in KKH or NUH

    • Intention to reside in Singapore for the next 5 years

    • Intention to donate cord, cord blood and placenta

    • The fetus should be racially homogenous with both sets of grandparents of the same ethnicity

    Exclusion Criteria:
    • Women whose pregnancies end in miscarriages will be excluded

    • Pregnant women on chemotherapy

    • Exclude women with significant medical conditions e.g. Type 1 diabetes mellitus, psychosis etc.

    • Exclude women on certain medications - e.g. psychotropic drugs.

    • Mixed marriages will be excluded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National University Hospital Singapore Singapore

    Sponsors and Collaborators

    • National University Hospital, Singapore
    • KK Women's and Children's Hospital
    • Singapore Institute for Clinical Sciences

    Investigators

    • Principal Investigator: Yap-Seng Chong, National University Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National University Hospital, Singapore
    ClinicalTrials.gov Identifier:
    NCT01174875
    Other Study ID Numbers:
    • CIRB/E/2019/2655
    • NMRC/TCR/004-NUS/2008
    • NMRC/TCR/012-NUHS/2014
    • MOH-000504
    First Posted:
    Aug 4, 2010
    Last Update Posted:
    Apr 12, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National University Hospital, Singapore
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2021