Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants

Adiposity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815385
• Other study ID #: 12-12-428
• Secondary ID: 1-13-CE-06
• Status: Completed
• Start date: March 2013
• Est. completion date: March 28, 2020

Study information

• Verified date: February 2021
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 28, 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Environmental Exposures
• Full Term Infants
• Obesity

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Jack D. Weiler Division	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure indices of adiposity in enrolled patients	Assessments will be performed within 72 hours of birth and at 1 and 2 years of age.	up to 24 months
Primary	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.	up to 12 months of age
Primary	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.	up to 12 months of age
Primary	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.	up to 12 months of age