Growing Up in Singapore Towards Healthy Outcomes (GUSTO)

January 20, 2023 updated by: National University Hospital, Singapore

Metabolic Health in Asian Women and Their Children

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.

Study Overview

Status

Active, not recruiting

Conditions

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 for over a decade. 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 Type

Observational

Enrollment (Actual)

1247

Contacts and Locations

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

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant mothers who are attending the first trimester antenatal visit at the public maternity units in KKH and NUH.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roles of fetal, developmental and epigenetic factors in pathways to disease
Time Frame: 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.
Perinatal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of prenatal and early postnatal factors on child health
Time Frame: 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.
During pregnancy and infancy period
Effect of factors in pregnancy and early postpartum period on maternal health
Time Frame: 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.
During pregnancy and postpartum period
Influence genetic and epigenetics factors in combination with lifestyle on child health
Time Frame: 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.
Childhood and Adolescence up to age 14

Collaborators and Investigators

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

Sponsor

National University Hospital, Singapore

Collaborators

KK Women's and Children's Hospital
Singapore Institute for Clinical Sciences

Investigators

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

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)

June 1, 2009

Primary Completion (Anticipated)

July 1, 2029

Study Completion (Anticipated)

July 1, 2029

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB/E/2019/2655
  • NMRC/TCR/004-NUS/2008 (Other Grant/Funding Number: National Medical Research Council)
  • NMRC/TCR/012-NUHS/2014 (Other Grant/Funding Number: National Medical Research Council)
  • MOH-000504 (Other Grant/Funding Number: National Medical Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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