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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:
Collaborators:
KK Women's and Children's Hospital
Singapore Institute for Clinical Sciences
Information provided by (Responsible Party):
Obstetrics & Gynaecology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01174875
First received: July 1, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.

Condition
Metabolic Diseases
Neurological and Mental Health Conditions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growing Up in Singapore Towards Healthy Outcomes

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Pattern of epigenetic marks in birth tissues [ Time Frame: Perinatal ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Influence of prenatal and early postnatal factors [ Time Frame: During pregnancy and infancy period ] [ Designated as safety issue: No ]
    Maternal nutrition, lifestyle, and emotional health and/or nutrition and other signals in infancy can influence the development of phenotypes in childhood that 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; Stool, nasal, buccal samples from the children breast milk from breastfeeding mothers


Enrollment: 1247
Study Start Date: June 2009
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant mothers, neonates, 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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174875

Locations
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
Principal Investigator: Yap-Seng Chong National University Health System
  More Information

Additional Information:
No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Obstetrics & Gynaecology, A/Prof. Chong Yap-Seng, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01174875     History of Changes
Other Study ID Numbers: D/09/021, NMRC/TCR/004-NUS/2008
Study First Received: July 1, 2010
Last Updated: January 2, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Epigenetics
Development
Metabolic
Neurodevelopment

Additional relevant MeSH terms:
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014