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NCT01815385 · ClinicalTrials.gov registry record
Epigenetic and Developmental Effects of In Utero Exposure to Environmental Toxicants
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 110
- Enrollment target
NCT01815385: Completed study, sponsored by Montefiore Medical Center.
NCT01815385 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815385 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 110 participants
- Enrollment target
Study 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.
Primary Outcome
Assessments will be performed within 72 hours of birth and at 1 and 2 years of age.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2013-03 |
| Est. Completion | 2020-03-28 |
What the finished NCT01815385 record still lists
NCT01815385 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01815385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815385 about?
NCT01815385 is a clinical study titled "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 fet...
What is the current status of trial NCT01815385?
This trial is currently completed. The enrollment target is 110 participants. The study started on 2013-03. Estimated completion is 2020-03-28.
Who is sponsoring clinical trial NCT01815385?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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