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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 : August 10, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center

Tracking Information
First Submitted Date January 10, 2018
First Posted Date January 18, 2018
Last Update Posted Date August 10, 2022
Actual Study Start Date September 1, 2018
Estimated Primary Completion Date March 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2018)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Childhood Obesity Programming by Intrauterine Growth Restriction
Official Title Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The investigators will collect cord and peripheral blood, buccal swab, urine and stool samples.
Sampling Method Probability Sample
Study Population Term AGA and IUGR singleton infants
Condition
  • Childhood Obesity
  • Epigenetics
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 17, 2018)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2030
Estimated Primary Completion Date March 2028   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Hour to 24 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mamta Fuloria, MD 718-904-4105 mfuloria@montefiore.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03402139
Other Study ID Numbers 2018-8749
R01HD092533 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Mamta Fuloria, Montefiore Medical Center
Original Responsible Party Same as current
Current Study Sponsor Montefiore Medical Center
Original Study Sponsor Same as current
Collaborators 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
PRS Account Montefiore Medical Center
Verification Date August 2022