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Early Childhood Obesity Programming by Intrauterine Growth Restriction

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ClinicalTrials.gov Identifier: NCT03402139
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center

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
Childhood Obesity Epigenetics

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.

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Study Type : Observational
Estimated 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 : September 1, 2018
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : December 31, 2024

Group/Cohort
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.



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
The investigators will collect cord and peripheral blood, buccal swab, urine and stool samples.


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Term AGA and IUGR singleton infants
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402139


Contacts
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Contact: Mamta Fuloria, MD 718-904-4105 mfuloria@montefiore.org

Locations
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United States, New York
Jack D. Weiler Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Mamta Fuloria, MD    718-904-4105    mfuloria@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Mamta Fuloria, MD Montefiore Medical Center/Albert Einstein College of Medicine

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Responsible Party: Mamta Fuloria, Associate Professor, Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03402139     History of Changes
Other Study ID Numbers: 2018-8749
R01HD092533 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Nutrition Disorders
Fetal Diseases
Growth Disorders
Fetal Growth Retardation
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Pregnancy Complications
Pathologic Processes