Actively Recruiting
Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
Led by Montefiore Medical Center · Updated on 2025-09-15
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how early childhood obesity develops in babies born with intrauterine growth restriction (IUGR), who are at higher risk for obesity and metabolic problems later in life. The study explores changes in DNA methylation of CD3+ T-cells, a type of immune cell, to uncover molecular mechanisms behind this developmental programming. It also examines how these changes relate to childhood body fat and health outcomes. The study observes two groups of infants: those with IUGR and those who are appropriate for gestational age (AGA). There are no treatments or interventions given; instead, researchers collect and analyze blood samples from the infants at birth, 12 months, and 24 months. They study the DNA methylation patterns and T-cell function to compare differences between the two groups over time. Participants will be followed from birth up to 24 months of age, with evaluations of growth speed, immune cell function, and DNA changes at specified ages. Cord blood and peripheral blood samples are collected to measure these factors. The study measures growth velocity, DNA methylation of CD3+ T-cells, and T-cell function at different time points to understand the relationship between early immune changes and childhood obesity risk.
CONDITIONS
Brief Title
Early Childhood Obesity Programming by Intrauterine Growth Restriction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy singleton term infants classified as either intrauterine growth restricted (IUGR) or appropriate for gestational age (AGA)
- Mothers followed by the Obstetric Department of Montefiore Medical Center delivering at the Weiler Division
- IUGR infants have birth weight below the 10th percentile for gestational age and gender based on WHO growth curves
- AGA infants have birth weight between the 10th and 90th percentile
- Mothers of reproductive age, healthy enough to achieve pregnancy
- Deliver a single healthy live infant at 37 weeks or more gestational age
- Informed consent provided according to institutional and federal guidelines
You will not qualify if you...
- Multiple gestation pregnancies
- Maternal depression
- Maternal renal disease
- Maternal smoking during the second and third trimester of pregnancy
- Maternal gestational diabetes or type 2 diabetes
- Preterm birth before 37 weeks gestation
- Known chromosomal or congenital abnormalities in the infant
- Infants in critical condition (extremis)
- Low Apgar scores (below 7 at 5 minutes)
- Known congenital bacterial or non-bacterial infections
- Known inborn errors of metabolism
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At birth
Participants provide cord and peripheral blood samples for DNA methylation and T-cell function analysis.
1 visit (in-person)
Duration - Until 24 months of age
Participants are observed to assess growth velocity, DNA methylation, and T-cell function over time.
3 visits at birth, 12 months, and 24 months (in-person)
Trial Site Locations
Total: 1 location
1
Jack D. Weiler Hospital
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
S
Sandra Reznik, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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