Early Childhood Obesity Programming by Intrauterine Growth Restriction

Childhood Obesity Clinical Trial

Official title:

Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402139
• Other study ID #: 2018-8749
• Secondary ID: R01HD092533
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: March 2028

Study information

• Verified date: August 2023
• Source: Montefiore Medical Center
• Contact: Mamta Fuloria, MD
• Phone: 718-904-4105
• Email: mfuloria[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Hour to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Epigenetics
• Fetal Growth Retardation
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital	Bronx	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth velocity	Change in growth velocity based on DNA methylation marks and functional profiles of CD3+ T-cells	Until 24 months of age
Primary	DNA methylation of CD3+ T-cells	Change in DNA methylation of CD3+ T-cells in the first 24 months of life in IUGR infants	At birth and 24 months of age
Primary	T-cell function	Change in T-cell function in the first 24 months of life in IUGR infants	At birth, 12 and 24 months of age