Early Childhood Obesity Programming by Intrauterine Growth Restriction

Recruiting

• Conditions: Epigenetics; Childhood Obesity

• Registration Number: NCT03402139
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Study Start: 2018-09-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15
• Primary Completion: 2028-03
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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

Exclusion Criteria

• Multiple gestation
• Maternal depression
• Maternal renal disease
• History of maternal smoking in the 2nd and 3rd trimester of pregnancy
• Maternal gestational diabetes / Type 2 Diabetes (T2D)
• Preterm birth (less than 37 weeks' gestation)
• Known chromosomal or congenital anomaly
• Infants in extremis
• Low Apgar scores (Apgar score <7 at 5 minutes of age)
• Known congenital bacterial or non-bacterial infections
• Known inborn errors of metabolism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Growth velocity	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	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	At birth, 12 and 24 months of age	Change in T-cell function in the first 24 months of life in IUGR infants

Trial Locations

Locations (1)

Jack D. Weiler Hospital; 🇺🇸 The Bronx, New York, United States