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

March 19, 2013
March 20, 2013
March 2013
August 2016   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01815385 on ClinicalTrials.gov Archive Site
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Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants
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.

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Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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

Probability Sample

Mother-baby pairs will be recruited.

  • Full Term Infants
  • Environmental Exposures
  • Adiposity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
August 2016
August 2016   (final data collection date for primary outcome measure)

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
Both
up to 72 Hours
Yes
Contact: Mamta Fuloria, MD 718-904-4105 mfuloria@montefiore.org
Contact: Deborah Campbell, MD 718-904-4105 dcampbel@montefiore.org
United States
 
NCT01815385
12-12-428, 1-13-CE-06
No
Mamta Fuloria, Montefiore Medical Center
Montefiore Medical Center
American Diabetes Association
Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center
Principal Investigator: Maureen Charron, PhD Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP