Early Childhood Obesity Programming by Intrauterine Growth Restriction

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03402139
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
400
1
147
2.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
    Actual Study Start Date :
    Sep 1, 2018
    Anticipated Primary Completion Date :
    Mar 1, 2028
    Anticipated Study Completion Date :
    Dec 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Growth velocity [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 [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 [At birth, 12 and 24 months of age]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Hour to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy singleton term IUGR and 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.
    Exclusion Criteria:
    • Multiple gestation, maternal depression, maternal renal disease, 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. We will also exclude infants born to mothers with a history of maternal smoking in the 2nd and 3rd trimester of pregnancy and maternal gestational diabetes/T2D.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jack D. Weiler Hospital Bronx New York United States 10461

    Sponsors and Collaborators

    • Montefiore Medical Center
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Mamta Fuloria, MD, Montefiore Medical Center/Albert Einstein College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mamta Fuloria, Associate Professor, Pediatrics, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03402139
    Other Study ID Numbers:
    • 2018-8749
    • R01HD092533
    First Posted:
    Jan 18, 2018
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2022