Full Term InfantsNCT01815385
Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants
An observational study of Full Term Infants and Environmental Exposures, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Full Term Infants, Environmental Exposures, Adiposity
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 28 Mar 2020
- 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 1 hour to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mother-baby pairs will be recruited.
Who may be able to join
- Infants whose mothers were followed by the Obstetric Department at MMC, and
- Deliver a single healthy live term infant
Who cannot join
- Multiple gestation,
- Maternal depression,
- History of maternal smoking in the 3rd trimester of pregnancy,
- Infants in extremis,
- Apgar score <7 at 5 min and umbilical artery pH ≤7.25,
- Chromosomal/congenital abnormalities,
- Congenital infections, and
- Inborn errors of metabolism
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center - Jack D. Weiler Division
The Bronx, New York, 10461
About this study
Official title: Early Life Exposure to Polycyclic Aromatic Hydrocarbons: Metabolic Perturbations and Epigenetic Biomarkers
Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong evidence suggests that alterations in the epigenome play a critical role in this process. The central hypothesis of this proposal is that intrauterine exposure to benzo[a]pyrene leads to epigenetic changes which will have functional consequences and may be a marker for, or may contribute to, increased susceptibility to adverse outcomes in childhood including increased adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The goals of this proposal are to: 1) determine benzo[a]pyrene levels in umbilical cord blood of newborns, 2) determine whether benzo[a]pyrene exposure during pregnancy correlates with early onset of obesity and metabolic disease by examining the children at 12 and 24 months of age, 3) determine whether in utero benzo[a]pyrene exposure programs metabolic disease through alterations in DNA methylation and gene expression, and 4) determine the plasticity of the DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of this project is to define biomarkers that identify neonates at "high-risk" for diminished attainment of full health potential, who can then be targeted for preventative measures.
- Conditions
- Full Term Infants, Environmental Exposures, Adiposity
- Keywords
- Term gestation, Environmental exposure, Benzo(a)pyrene, Polycyclic aromatic hydrocarbons, Adiposity, Cytosine methylation
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure indices of adiposity in enrolled patients
Assessments will be performed within 72 hours of birth and at 1 and 2 years of age.
Measured: up to 24 months
Measure benzo(a)pyrene levels in blood samples
Benzo(a)pyrene levels will be measured in cord blood samples obtained at birth and in peripheral blood samples obtained at 12 months of age.
Measured: up to 12 months of age
Measure tobacco by-products in blood samples
Levels of tobacco by-products will be measured in cord blood samples obtained at birth and in peripheral blood samples obtained at 12 months of age.
Measured: up to 12 months of age
Characterize cytosine methylation changes in CD3+ T-lymphocytes
Cytosine methylation changes in CD3+ T-lymphocytes will be characterized in cord blood and in a peripheral blood sample obtained at 12 months of age.
Measured: up to 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2018
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Term InfantsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Mamta Fuloria, Montefiore Medical Center
- Investigators
- Mamta Fuloria, MD, Principal investigator, Montefiore Medical CenterMaureen Charron, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815385
- Sponsor's protocol ID
- 12-12-428
- Other IDs
- 1-13-CE-06
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2013
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Life Exposure to Polycyclic Aromatic Hydrocarbons: Metabolic Perturbations and Epigenetic Biomarkers
- ClinicalTrials.gov ID
- NCT01815385
- Acronym / sponsor ID
- 12-12-428
- Conditions
- Full Term Infants, Environmental Exposures, Adiposity
- Keywords
- Term gestation, Environmental exposure, Benzo(a)pyrene, Polycyclic aromatic hydrocarbons, Adiposity, Cytosine methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 21 Mar 2013 (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.
Metabolic diseases such as obesity and diabetes are modern day epidemics. Early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. Although the mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong evidence suggests that alterations in the epigenome play a critical role in this process. The central hypothesis of this proposal is that intrauterine exposure to benzo[a]pyrene leads to epigenetic changes which will have functional consequences and may be a marker for, or may contribute to, increased susceptibility to adverse outcomes in childhood including increased adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. The goals of this proposal are to: 1) determine benzo[a]pyrene levels in umbilical cord blood of newborns, 2) determine whether benzo[a]pyrene exposure during pregnancy correlates with early onset of obesity and metabolic disease by examining the children at 12 and 24 months of age, 3) determine whether in utero benzo[a]pyrene exposure programs metabolic disease through alterations in DNA methylation and gene expression, and 4) determine the plasticity of the DNA methylation patterns in the same offspring at 12 months of age. The long-term goal of this project is to define biomarkers that identify neonates at "high-risk" for diminished attainment of full health potential, who can then be targeted for preventative measures.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mother-baby pairs will be recruited.
Key inclusion criteria (2 listed)
- Infants whose mothers were followed by the Obstetric Department at MMC, and
- Deliver a single healthy live term infant
Key exclusion criteria (8 listed)
- Multiple gestation,
- Maternal depression,
- History of maternal smoking in the 3rd trimester of pregnancy,
- Infants in extremis,
- Apgar score <7 at 5 min and umbilical artery pH ≤7.25,
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
Measure indices of adiposity in enrolled patients
Time frame: up to 24 months
Assessments will be performed within 72 hours of birth and at 1 and 2 years of age.
Measure benzo(a)pyrene levels in blood samples
Time frame: up to 12 months of age
Benzo(a)pyrene levels will be measured in cord blood samples obtained at birth and in peripheral blood samples obtained at 12 months of age.
Measure tobacco by-products in blood samples
Time frame: up to 12 months of age
Levels of tobacco by-products will be measured in cord blood samples obtained at birth and in peripheral blood samples obtained at 12 months of age.
Characterize cytosine methylation changes in CD3+ T-lymphocytes
Time frame: up to 12 months of age
Cytosine methylation changes in CD3+ T-lymphocytes will be characterized in cord blood and in a peripheral blood sample obtained at 12 months of age.
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 11 Feb 2021.
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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.
Mamta Fuloria, MD principal investigator
Montefiore Medical Center
Maureen Charron, PhD principal investigator
Albert Einstein College of Medicine
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 Full Term Infants and Environmental Exposures, run by Montefiore Medical Center at 1 site in United States.
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 2 inclusion and 8 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 11 Feb 2021. 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 United States. 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.
What does the primary outcome measure?
Measure indices of adiposity in enrolled patients (time frame: up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 Feb 2021.