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NCT Number: NCT03402139

Early Childhood Obesity Programming by Intrauterine Growth Restriction

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.

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Key information

Age range

1 hour–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

Location status: Recruiting

Location contact

Mamta Fuloria, MD

CONTACT

[email protected]

718-904-4105

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Mother-infant pairs will be recruited for this study.

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

  • 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

Treatment and study plan

Primary outcomes

  1. Growth velocity

    Time frame: Until 24 months of age

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

  2. DNA methylation of CD3+ T-cells

    Time frame: At birth and 24 months of age

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

  3. T-cell function

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Reznik, MD

CONTACT

[email protected]

718-904-2947

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Gencove
  • Hackensack Meridian Health Center for Discovery and Innovation
  • Icahn School of Medicine at Mount Sinai
  • University of California, San Francisco
  • University of Wisconsin, Madison

Registry information

Official study title

Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jan 18, 2018
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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