Fetal Growth RetardationNCT00510380
Epigenetic Markers in Growth Restricted Human Pregnancies: a Case-controlled Study
An observational study of Fetal Growth Retardation, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Retardation
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2007to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Babies from Chinese women with single pregnancies
Who may be able to join
- Chinese women,
- Singleton pregnancies,
- fetal growth restriction diagnosed clinically and by ultrasound parameters,
- Normally grown fetuses by clinical and ultrasound criteria
Who cannot join
- Non-Chinese women
- Multiple pregnancies
- Co-existing antenatal complications including sever pre-eclampsia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic Markets in Growth Restricted Human Pregnancies: A Case- Control Study
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.
Read the 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.
- Conditions
- Fetal Growth Retardation
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| growth-restricted Chinese pregnancies | Not described | |
| appropriately-grown Chinese pregnancies | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startApr 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Yap Seng Chong, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510380
- Sponsor's protocol ID
- SIG/07072
- Status last verified
- Sep 2009
- First submitted
- 1 Aug 2007
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Markets in Growth Restricted Human Pregnancies: A Case- Control Study
- ClinicalTrials.gov ID
- NCT00510380
- Acronym / sponsor ID
- SIG/07072
- Conditions
- Fetal Growth Retardation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| growth-restricted Chinese pregnancies | – | – |
| appropriately-grown Chinese pregnancies | – | – |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Babies from Chinese women with single pregnancies
Key inclusion criteria (4 listed)
- Chinese women,
- Singleton pregnancies,
- fetal growth restriction diagnosed clinically and by ultrasound parameters,
- Normally grown fetuses by clinical and ultrasound criteria
Key exclusion criteria (3 listed)
- Non-Chinese women
- Multiple pregnancies
- Co-existing antenatal complications including sever pre-eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yap Seng Chong, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Retardation, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009.