Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Montefiore Medical Center
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01815385
First received: March 19, 2013
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition
Full Term Infants
Environmental Exposures
Adiposity

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Early Life Exposure to Polycyclic Aromatic Hydrocarbons: Metabolic Perturbations and Epigenetic Biomarkers

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Measure indices of adiposity in enrolled patients [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Maternal blood sample Cord blood sample Infant saliva Peripheral blood sample from enrolled patients at 12 and 24 months of age


Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Mother-baby pairs will be recruited.

Criteria

Inclusion Criteria:

  • Infants whose mothers were followed by the Obstetric Department at MMC, and
  • Deliver a single healthy live term infant

Exclusion Criteria:

  • 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
  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: NCT01815385

Contacts
Contact: Mamta Fuloria, MD 718-904-4105 mfuloria@montefiore.org
Contact: Deborah Campbell, MD 718-904-4105 dcampbel@montefiore.org

Locations
United States, New York
Montefiore Medical Center - Jack D. Weiler Division Recruiting
Bronx, New York, United States, 10461
Contact: Mamta Fuloria, MD    718-904-4105    mfuloria@montefiore.org   
Contact: Deborah Campbell, MD    718-904-4105    dcampbel@montefiore.org   
Principal Investigator: Mamta Fuloria, MD         
Principal Investigator: Maureen Charron, PhD         
Sub-Investigator: Francine Einstein, MD         
Sub-Investigator: Deborah Campbell, MD         
Sponsors and Collaborators
Montefiore Medical Center
American Diabetes Association
Investigators
Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center
Principal Investigator: Maureen Charron, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Mamta Fuloria, Assistant Professor, Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01815385     History of Changes
Other Study ID Numbers: 12-12-428, 1-13-CE-06
Study First Received: March 19, 2013
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Montefiore Medical Center:
Term gestation
Environmental exposure
Benzo(a)pyrene
Polycyclic aromatic hydrocarbons
Adiposity
Cytosine methylation

ClinicalTrials.gov processed this record on October 23, 2014