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Growing Up in Singapore Towards Healthy Outcomes (GUSTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01174875
Recruitment Status : Active, not recruiting
First Posted : August 4, 2010
Last Update Posted : January 23, 2023
Sponsor:
Collaborators:
KK Women's and Children's Hospital
Singapore Institute for Clinical Sciences
Information provided by (Responsible Party):
National University Hospital, Singapore

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
Metabolic Diseases Neurological and Mental Health 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.

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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 : June 2009
Estimated Primary Completion Date : July 2029
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
During pregnancy; Mother: blood, buccal and hair samples. At delivery; cord, cord blood and placenta. During infancy and childhood; Stool, nasal, buccal samples, saliva, urine, blood and exfoliated teeth from the children, breast milk from breastfeeding mothers


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

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): NCT01174875


Locations
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Singapore
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
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Principal Investigator: Yap-Seng Chong National University Health System
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01174875    
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 )
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 National University Hospital, Singapore:
Epigenetics
Development
Metabolic
Neurodevelopment
Additional relevant MeSH terms:
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Metabolic Diseases