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.
Brief Title
Early Childhood Obesity Programming by Intrauterine Growth Restriction
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-904-4105
Central Contact Email
mfuloria@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Childhood Obesity
Epigenetics
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
24 Months
Minimum Age
1 Hour
NCT Id
NCT03402139
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-8749
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
Primary Outcomes
Outcome Description
Change in growth velocity based on DNA methylation marks and functional profiles of CD3+ T-cells
Outcome Measure
Growth velocity
Outcome Time Frame
Until 24 months of age
Outcome Description
Change in DNA methylation of CD3+ T-cells in the first 24 months of life in IUGR infants
Outcome Measure
DNA methylation of CD3+ T-cells
Outcome Time Frame
At birth and 24 months of age
Outcome Description
Change in T-cell function in the first 24 months of life in IUGR infants
Outcome Measure
T-cell function
Outcome Time Frame
At birth, 12 and 24 months of age
Secondary Ids
Secondary Id
R01HD092533
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Term AGA and IUGR singleton infants
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
2
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mamta Fuloria
Investigator Email
MFULORIA@montefiore.org
Investigator Phone
718-904-2821