Early Childhood Obesity Programming by Intrauterine Growth Restriction

NCT03402139 | Recruiting

• 2 other identifiers: 2018-8749R01HD092533
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity; Epigenetics

Outcome Measures

Primary Outcomes (3)

• Growth velocity

  Change in growth velocity based on DNA methylation marks and functional profiles of CD3+ T-cells

  Until 24 months of age

• 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

• 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

Study Arms (2)

IUGR infants

Intrauterine growth restricted infants will be enrolled. There are no interventions.

AGA infants

Appropriate for gestational age infants will be enrolled. There are no interventions.

Eligibility Criteria

• Age: 1 Hour - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Term AGA and IUGR singleton infants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• 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

Study Sites (1)

Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will collect cord and peripheral blood, buccal swab, urine and stool samples.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Reznik, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Reznik, MD

CONTACT

718-904-2947; sreznik@montefiore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: September 1, 2018
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)