Epigenetic Markers in Growth Restricted Human Pregnancies: a Case-controlled Study

This study has been completed.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00510380
First received: August 1, 2007
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

This study is carried out to discover if a baby with restricted growth in the womb is subject to specific fetal programming which predisposes to the metabolic syndrome(diabetes,hypertension,heart disease) in adulthood.We have elected to first study this condition in Chinese population in Singapore with the eventual plan of studying all ethnic groups. This is important for understanding the molecular basis of adult-onset disease such as diabetes, identifying children at risk of developing this disease in future and targeting specific strategies for intervention and disease prevention.

Intrauterine fetal programming is effected through epigenetic changes similar to those previously identified in animal studies. The epigenetic markers can be found in growth restricted Chinese pregnancies in the local population.


Condition
Fetal Growth Retardation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Epigenetic Markets in Growth Restricted Human Pregnancies: A Case- Control Study

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

Estimated Enrollment: 40
Study Start Date: April 2007
Study Completion Date: April 2009
Groups/Cohorts
growth-restricted Chinese pregnancies
appropriately-grown Chinese pregnancies

Detailed Description:

Fetal growth restriction is associated with accelerated postnatal weight gain and increased obesity risk in later life.International epidemiological data suggest that the phenomenon of fetal programming links poor intrauterine growth to adult disease, primarily type II diabetes, obesity and metabolic syndrome, conditions increasingly common in Singapore. Suboptimal intrauterine environmental condition s are postulated to affect fetal development through effects on developmental plasticity through epigenetic processes. These effects manifest as poor glucose resistance, insulin resistance, obesity and cardiovascular disease in later life. There is increasing animal data to support this model.

The aim of this study is to determine if epigenetic markers of the metabolic syndrome are present in selected Chinese pregnancies in Singapore.

Hypothesis:

Intrauterine fetal programming is effected through epigenetic changes similar to those previously identified in animal studies. The epigenetic markers can be found in growth restricted Chinese pregnancies in the local population.

Methodology Umbilical cords and cord blood will be collected from twenty unequivocally growth-restricted Chinese pregnancies and twenty appropriately-grown Chinese pregnancies. DNA extracted from these tissues will be subjected to a custom-made DNA methylation array probing for specific changes in 262 candidate genes important to fetal endocrine and metabolic control.

This will be done using either a methylation array or a Sequenorn 2 in the DNA extracts that have been identified through Epigen academic consortium of the Liggins Institute and UK collaborators.

Anthropometric data will be collected from the infants at birth, and subsequently at 3,6,12,18 and 24 months and we will seek differential measures of programming.

Application The discovery of biomarkers indicating shifted developmental trajectories is the most important need in developmental programming research. Birth weight alone is not a valid measure. Biomarkers predictive of later obesity and the metabolic syndrome will be invaluable in formulating preventive strategies for these diseases.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Babies from Chinese women with single pregnancies

Criteria

Inclusion Criteria:

  1. Chinese women,
  2. Singleton pregnancies,
  3. fetal growth restriction diagnosed clinically and by ultrasound parameters,
  4. Normally grown fetuses by clinical and ultrasound criteria

Exclusion Criteria:

  1. Non-Chinese women
  2. Multiple pregnancies
  3. Co-existing antenatal complications including sever pre-eclampsia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00510380

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Yap Seng Chong, MBBS National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Chong Yap Seng, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00510380     History of Changes
Other Study ID Numbers: SIG/07072
Study First Received: August 1, 2007
Last Updated: September 18, 2009
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Growth Disorders
Pathologic Processes
Pregnancy Complications

ClinicalTrials.gov processed this record on October 30, 2014