Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants

NCT ID: NCT01815385

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2020-03-28

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.

Conditions

Full Term Infants; Environmental Exposures; Adiposity

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mamta Fuloria

Associate Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mamta Fuloria, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Maureen Charron, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Montefiore Medical Center - Jack D. Weiler Division

The Bronx, New York, United States

Countries

United States

Other Identifiers

1-13-CE-06

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12-12-428

Identifier Type: -

Identifier Source: org_study_id