Early Childhood Obesity Programming by Intrauterine Growth Restriction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-24
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Multiple gestation
Maternal depression
Maternal renal disease
History of maternal smoking in the 2nd and 3rd trimester of pregnancy
Trial population
Term AGA and IUGR singleton infants
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 2 trial groupsGroup A: IUGR infants
Group B: AGA infants
Trial outcomes
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 age2
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 age3
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 ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Montefiore Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Hackensack Meridian Health Center for Discovery and Innovation
Collaborator
University of California, San Francisco
Collaborator
University of Wisconsin, Madison
Collaborator
Gencove
Collaborator
Source ClinicalTrials.gov