Early Childhood Obesity Programming by Intrauterine Growth Restriction

Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03402139

Enrollment

163

Registered

2018-01-18

Start date

2018-09-01

Completion date

2021-12-19

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Epigenetics

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 24 Months

Healthy volunteers

Yes

Inclusion criteria

Mother-infant pairs will be recruited for this study. 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSandra Reznik, MD

Montefiore Medical Center/Albert Einstein College of Medicine

Outcome results