Investigating how early growth restriction affects childhood obesity
Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
This study is trying to see how early growth issues in newborns might lead to obesity in childhood by looking at changes in their immune cells.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 1 Hour to 24 Months |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT03402139 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the molecular mechanisms that contribute to childhood obesity in infants who experienced intrauterine growth restriction (IUGR). Researchers will analyze CD3+ T-cells from IUGR newborns to explore how changes in DNA methylation may influence obesity and metabolic disorders later in life. By correlating these molecular changes with childhood adiposity, the study seeks to uncover critical insights into the developmental programming of obesity. The research is conducted at Montefiore Medical Center, focusing on healthy singleton term infants.
Who should consider this trial
Good fit: Ideal candidates include healthy singleton term infants who are either IUGR or appropriate for gestational age (AGA) and whose mothers are receiving care at Montefiore Medical Center.
Not a fit: Patients who may not benefit include those with multiple gestations, significant maternal health issues, or congenital abnormalities.
Why it matters
Potential benefit: If successful, this study could provide insights into preventing childhood obesity and related metabolic disorders in at-risk populations.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a link between early growth patterns and later obesity, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
The Bronx, New York
- Jack D. Weiler Hospital — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sandra Reznik, MD — Montefiore Medical Center/Albert Einstein College of Medicine
- Study coordinator: Sandra Reznik, MD
- Email: sreznik@montefiore.org
- Phone: 718-904-2947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.