CClinicalTrials.gg
CompletedNCT03402139Updated Aug 31, 2026

Early Childhood Obesity Programming by Intrauterine Growth Restriction

An observational study in Childhood Obesity and Epigenetics, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 1 Hour to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Montefiore Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
163
Ages
1 Hour to 24 Months
Sex
All
01

Study summary

The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life.

Read the detailed description

Epidemiological studies of multiple cohorts suggest an increased risk for obesity, cardiovascular disease-related death and type 2 diabetes in low birth weight infants. However, the molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Alterations in DNA methylation during fetal life have been proposed to be one of the mechanisms that regulate this phenotype. Here, the investigators address major questions about early childhood obesity programming by studying purified subpopulations of CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life. The investigators will correlate altered CD3+ T-cell DNA methylation profiles in cord and peripheral blood samples and functional changes in CD3+ T-cells with adiposity in childhood.

02

Conditions studied

  • Childhood Obesity
  • Epigenetics

Browse trials for

03

Who can participate

Ages eligible
1 Hour to 24 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Term AGA and IUGR singleton infants

Mother-infant pairs will be recruited for this study.

Inclusion criteria

Inclusion Criteria:

  • Healthy singleton term intrauterine growth restricted (IUGR) and appropriate for gestational age (AGA) infants whose mothers are followed by the Obstetric Department of Montefiore Medical Center and who deliver at the Weiler Division of Montefiore Medical Center. Infants will be classified as IUGR if birth weight is \<10th percentile for gestational age and gender based on World Health Organization (WHO) growth curves. Infants will be classified as AGA if birth weight percentile is >10th and \<90th percentile
  • Reproductive age women, healthy enough to achieve pregnancy
  • Deliver a single healthy live term infant at ≥37 weeks' gestational age (GA)
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion criteria

Exclusion Criteria:

  • Multiple gestation
  • Maternal depression
  • Maternal renal disease
  • History of maternal smoking in the 2nd and 3rd trimester of pregnancy
  • Maternal gestational diabetes / Type 2 Diabetes (T2D)
  • Preterm birth (less than 37 weeks' gestation)
  • Known chromosomal or congenital anomaly
  • Infants in extremis
  • Low Apgar scores (Apgar score \<7 at 5 minutes of age)
  • Known congenital bacterial or non-bacterial infections
  • Known inborn errors of metabolism
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
163 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • IUGR infants

    Intrauterine growth restricted infants will be enrolled. There are no interventions.

  • AGA infants

    Appropriate for gestational age infants will be enrolled. There are no interventions.

05

What researchers measure

Primary outcomes

  1. Growth velocity

    Change in growth velocity based on DNA methylation marks and functional profiles of CD3+ T-cells

    Time frame: Until 24 months of age

  2. DNA methylation of CD3+ T-cells

    Change in DNA methylation of CD3+ T-cells in the first 24 months of life in IUGR infants

    Time frame: At birth and 24 months of age

  3. T-cell function

    Change in T-cell function in the first 24 months of life in IUGR infants

    Time frame: At birth, 12 and 24 months of age

06

Study locations

1 site
  • Jack D. Weiler Hospital
    The Bronx, New York 10461, United States
07

References and documents

Publications

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Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03402139
Lead sponsor
Montefiore Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Icahn School of Medicine at Mount Sinai, Hackensack Meridian Health Center for Discovery and Innovation, University of California, San Francisco, University of Wisconsin, Madison, Gencove, U.S. National Science Foundation, National Institutes of Health (NIH), Relay Therapeutics, Inc., Merck Sharp & Dohme LLC, American Federation for Aging Research, Leukemia Research Foundation, St. John's University, National Institute of General Medical Sciences (NIGMS)
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Sep 1, 2018
Primary completion
Dec 19, 2021
Completion
Dec 19, 2021
Last update
Aug 31, 2026

Study contacts

Sandra Reznik, MD
principal investigator · Montefiore Medical Center/Albert Einstein College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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