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Developmental Pathways to Health and Disease: Metabolic, Neurodevelopmental and Related Outcomes. (GUSTO)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01174875
First Posted: August 4, 2010
Last Update Posted: February 8, 2017
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.
Collaborators:
KK Women's and Children's Hospital
Singapore Institute for Clinical Sciences
Information provided by (Responsible Party):
Obstetrics & Gynaecology, National University Hospital, Singapore
July 1, 2010
August 4, 2010
February 8, 2017
June 2009
June 2020   (Final data collection date for primary outcome measure)
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.
The pattern of epigenetic marks in birth tissues [ Time Frame: Perinatal ]
To examine how epigenetic change at birth both reflects past developmental influences and, in association with other factors, influences future trajectories of development and its relationship to metabolic risk.
Complete list of historical versions of study NCT01174875 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Influence of prenatal factors [ Time Frame: During pregnancy and infancy period of the child ]
The influence of prenatal factors as predictors of epigenetic variants, body composition at birth, and early postnatal growth
Not Provided
Not Provided
 
Developmental Pathways to Health and Disease: Metabolic, Neurodevelopmental and Related Outcomes.
Growing Up in Singapore Towards Healthy Outcomes

This study aims to test the following two hypotheses in women recruited in early pregnancy and whose children will be followed up till at least 9 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.
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 among Asians and in the ethnic variation between BMI and the risk of developing insulin resistance. Apart from genetic factors, the differences in diet, lifestyle, cultural and religious practices might have altered the developmental programming through effects on the mechanisms of developmental plasticity. A center piece of this study is to examine how epigenetic change at birth both reflects past developmental influences and, in association with other factors, influences future trajectories of development and its relationship to NCDs. The longitudinal GUSTO birth cohort study allow us to examine associations between genomic variation and developmental-environmental interactions in the three distinct ethnic groups, Chinese, Malays and Indians, present in the Singaporean population.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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
Non-Probability Sample
Pregnant mothers who are attending the first trimester antenatal visit at the public maternity units in KKH and NUH.
  • Metabolic Diseases
  • Neurological and Mental Health Conditions
Not Provided
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 9 years of age.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1247
June 2020
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01174875
D/09/021
NMRC/TCR/004-NUS/2008 ( Other Identifier: National Medical Research Council, )
No
Not Provided
Plan to Share IPD: No
Obstetrics & Gynaecology, National University Hospital, Singapore
National University Hospital, Singapore
  • KK Women's and Children's Hospital
  • Singapore Institute for Clinical Sciences
Principal Investigator: Yap-Seng Chong National University Health System
National University Hospital, Singapore
February 2017