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NCT Number: NCT01815385

Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants

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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Key information

Conditions

Full Term Infants Adiposity Body Weight Environmental Exposures Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 hour–72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center - Jack D. Weiler Division

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Early Life Exposure to Polycyclic Aromatic Hydrocarbons: Metabolic Perturbations and Epigenetic Biomarkers

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Mar 21, 2013
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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