Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01815385
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Last Update Posted : January 11, 2018
American Diabetes Association
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center

Brief 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. 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 or disease
Full Term Infants Environmental Exposures Adiposity

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Early Life Exposure to Polycyclic Aromatic Hydrocarbons: Metabolic Perturbations and Epigenetic Biomarkers
Study Start Date : March 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

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

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Mother-baby pairs will be recruited.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01815385

United States, New York
Montefiore Medical Center - Jack D. Weiler Division
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
American Diabetes Association
Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center
Principal Investigator: Maureen Charron, PhD Albert Einstein College of Medicine, Inc.

Responsible Party: Mamta Fuloria, Assistant Professor, Pediatrics, Montefiore Medical Center Identifier: NCT01815385     History of Changes
Other Study ID Numbers: 12-12-428
1-13-CE-06 ( Other Grant/Funding Number: American Diabetes Association )
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Mamta Fuloria, Montefiore Medical Center:
Term gestation
Environmental exposure
Polycyclic aromatic hydrocarbons
Cytosine methylation

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms