Childhood ObesityNCT03402139
Early Childhood Obesity Programming by Intrauterine Growth Restriction
An observational study of Childhood Obesity and Epigenetics, run by Montefiore Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 hour to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Epigenetics
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 19 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term AGA and IUGR singleton infants
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
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.
Read the 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.
- Conditions
- Childhood Obesity, Epigenetics
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity
Change in growth velocity based on DNA methylation marks and functional profiles of CD3+ T-cells
Measured: 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
Measured: 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
Measured: At birth, 12 and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Sep 2018
- Primary completion19 Dec 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Icahn School of Medicine at Mount Sinai, Hackensack Meridian Health Center for Discovery and Innovation, University of California, San Francisco, University of Wisconsin, Madison, Gencove, U.S. National Science Foundation, National Institutes of Health (NIH), Relay Therapeutics, Inc., Merck Sharp & Dohme LLC, American Federation for Aging Research, Leukemia Research Foundation, St. John's University, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Sandra Reznik, MD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402139
- Sponsor's protocol ID
- 2018-8749
- Other IDs
- R01HD092533, 1R16GM145586, 1S10OD030286-01
- Status last verified
- Aug 2026
- First submitted
- 10 Jan 2018
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGuire S. Institute of Medicine and National Research Council. Examining a developmental approach to childhood obesity: the fetal and early childhood years: workshop in brief. Washington, DC: The National Academies Press, 2015. Adv Nutr. 2015 Jul 15;6(4):487-8. doi: 10.3945/an.115.009381. Print 2015 Jul. No abstract available.
PubMed 26178032Woo Baidal JA, Locks LM, Cheng ER, Blake-Lamb TL, Perkins ME, Taveras EM. Risk Factors for Childhood Obesity in the First 1,000 Days: A Systematic Review. Am J Prev Med. 2016 Jun;50(6):761-779. doi: 10.1016/j.amepre.2015.11.012. Epub 2016 Feb 22.
PubMed 26916261Baker JL, Olsen LW, Sorensen TI. Weight at birth and all-cause mortality in adulthood. Epidemiology. 2008 Mar;19(2):197-203. doi: 10.1097/EDE.0b013e31816339c6.
PubMed 18300695Pettitt DJ, Jovanovic L. Birth weight as a predictor of type 2 diabetes mellitus: the U-shaped curve. Curr Diab Rep. 2001 Aug;1(1):78-81. doi: 10.1007/s11892-001-0014-x.
PubMed 12762961Pettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8. doi: 10.2337/diab.37.5.622.
PubMed 3360218Olsen LW, Baker JL, Holst C, Sorensen TI. Birth cohort effect on the obesity epidemic in Denmark. Epidemiology. 2006 May;17(3):292-5. doi: 10.1097/01.ede.0000208349.16893.e0.
PubMed 16570023Araujo de Franca GV, De Lucia Rolfe E, Horta BL, Gigante DP, Yudkin JS, Ong KK, Victora CG. Associations of birth weight, linear growth and relative weight gain throughout life with abdominal fat depots in adulthood: the 1982 Pelotas (Brazil) birth cohort study. Int J Obes (Lond). 2016 Jan;40(1):14-21. doi: 10.1038/ijo.2015.192. Epub 2015 Sep 23.
PubMed 26395747Jornayvaz FR, Vollenweider P, Bochud M, Mooser V, Waeber G, Marques-Vidal P. Low birth weight leads to obesity, diabetes and increased leptin levels in adults: the CoLaus study. Cardiovasc Diabetol. 2016 May 3;15:73. doi: 10.1186/s12933-016-0389-2.
PubMed 27141948Jaquet D, Vidal H, Hankard R, Czernichow P, Levy-Marchal C. Impaired regulation of glucose transporter 4 gene expression in insulin resistance associated with in utero undernutrition. J Clin Endocrinol Metab. 2001 Jul;86(7):3266-71. doi: 10.1210/jcem.86.7.7677.
PubMed 11443199McMillen IC, Robinson JS. Developmental origins of the metabolic syndrome: prediction, plasticity, and programming. Physiol Rev. 2005 Apr;85(2):571-633. doi: 10.1152/physrev.00053.2003.
PubMed 15788706Thorn SR, Rozance PJ, Brown LD, Hay WW Jr. The intrauterine growth restriction phenotype: fetal adaptations and potential implications for later life insulin resistance and diabetes. Semin Reprod Med. 2011 May;29(3):225-36. doi: 10.1055/s-0031-1275516. Epub 2011 Jun 27.
PubMed 21710398Crume TL, Scherzinger A, Stamm E, McDuffie R, Bischoff KJ, Hamman RF, Dabelea D. The long-term impact of intrauterine growth restriction in a diverse U.S. cohort of children: the EPOCH study. Obesity (Silver Spring). 2014 Feb;22(2):608-15. doi: 10.1002/oby.20565. Epub 2013 Sep 17.
PubMed 23836432Eriksson JG, Forsen T, Tuomilehto J, Winter PD, Osmond C, Barker DJ. Catch-up growth in childhood and death from coronary heart disease: longitudinal study. BMJ. 1999 Feb 13;318(7181):427-31. doi: 10.1136/bmj.318.7181.427.
PubMed 9974455Cianfarani S, Germani D, Branca F. Low birthweight and adult insulin resistance: the "catch-up growth" hypothesis. Arch Dis Child Fetal Neonatal Ed. 1999 Jul;81(1):F71-3. doi: 10.1136/fn.81.1.f71. No abstract available.
PubMed 10375369Huxley RR, Shiell AW, Law CM. The role of size at birth and postnatal catch-up growth in determining systolic blood pressure: a systematic review of the literature. J Hypertens. 2000 Jul;18(7):815-31. doi: 10.1097/00004872-200018070-00002.
PubMed 10930178
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
- ClinicalTrials.gov ID
- NCT03402139
- Acronym / sponsor ID
- 2018-8749
- Conditions
- Childhood Obesity, Epigenetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Icahn School of Medicine at Mount Sinai, Hackensack Meridian Health Center for Discovery and Innovation, University of California, San Francisco, University of Wisconsin, Madison, Gencove, U.S. National Science Foundation, National Institutes of Health (NIH), Relay Therapeutics, Inc., Merck Sharp & Dohme LLC, American Federation for Aging Research, Leukemia Research Foundation, St. John's University, National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 hour to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term AGA and IUGR singleton infants
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth velocity
Time frame: 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
Time frame: 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
Time frame: At birth, 12 and 24 months of age
Change in T-cell function in the first 24 months of life in IUGR infants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 26178032McGuire S. Institute of Medicine and National Research Council. Examining a developmental approach to childhood obesity: the fetal and early childhood years: workshop in brief. Washington, DC: The National Academies Press, 2015. Adv Nutr. 2015 Jul 15;6(4):487-8. doi: 10.3945/an.115.009381. Print 2015 Jul. No abstract available.
- Background: PubMed 26916261Woo Baidal JA, Locks LM, Cheng ER, Blake-Lamb TL, Perkins ME, Taveras EM. Risk Factors for Childhood Obesity in the First 1,000 Days: A Systematic Review. Am J Prev Med. 2016 Jun;50(6):761-779. doi: 10.1016/j.amepre.2015.11.012. Epub 2016 Feb 22.
- Background: PubMed 18300695Baker JL, Olsen LW, Sorensen TI. Weight at birth and all-cause mortality in adulthood. Epidemiology. 2008 Mar;19(2):197-203. doi: 10.1097/EDE.0b013e31816339c6.
- Background: PubMed 12762961Pettitt DJ, Jovanovic L. Birth weight as a predictor of type 2 diabetes mellitus: the U-shaped curve. Curr Diab Rep. 2001 Aug;1(1):78-81. doi: 10.1007/s11892-001-0014-x.
- Background: PubMed 3360218Pettitt DJ, Aleck KA, Baird HR, Carraher MJ, Bennett PH, Knowler WC. Congenital susceptibility to NIDDM. Role of intrauterine environment. Diabetes. 1988 May;37(5):622-8. doi: 10.2337/diab.37.5.622.
- Background: PubMed 16570023Olsen LW, Baker JL, Holst C, Sorensen TI. Birth cohort effect on the obesity epidemic in Denmark. Epidemiology. 2006 May;17(3):292-5. doi: 10.1097/01.ede.0000208349.16893.e0.
- Background: PubMed 26395747Araujo de Franca GV, De Lucia Rolfe E, Horta BL, Gigante DP, Yudkin JS, Ong KK, Victora CG. Associations of birth weight, linear growth and relative weight gain throughout life with abdominal fat depots in adulthood: the 1982 Pelotas (Brazil) birth cohort study. Int J Obes (Lond). 2016 Jan;40(1):14-21. doi: 10.1038/ijo.2015.192. Epub 2015 Sep 23.
- Background: PubMed 27141948Jornayvaz FR, Vollenweider P, Bochud M, Mooser V, Waeber G, Marques-Vidal P. Low birth weight leads to obesity, diabetes and increased leptin levels in adults: the CoLaus study. Cardiovasc Diabetol. 2016 May 3;15:73. doi: 10.1186/s12933-016-0389-2.
- Background: PubMed 11443199Jaquet D, Vidal H, Hankard R, Czernichow P, Levy-Marchal C. Impaired regulation of glucose transporter 4 gene expression in insulin resistance associated with in utero undernutrition. J Clin Endocrinol Metab. 2001 Jul;86(7):3266-71. doi: 10.1210/jcem.86.7.7677.
- Background: PubMed 15788706McMillen IC, Robinson JS. Developmental origins of the metabolic syndrome: prediction, plasticity, and programming. Physiol Rev. 2005 Apr;85(2):571-633. doi: 10.1152/physrev.00053.2003.
- Background: PubMed 21710398Thorn SR, Rozance PJ, Brown LD, Hay WW Jr. The intrauterine growth restriction phenotype: fetal adaptations and potential implications for later life insulin resistance and diabetes. Semin Reprod Med. 2011 May;29(3):225-36. doi: 10.1055/s-0031-1275516. Epub 2011 Jun 27.
- Background: PubMed 23836432Crume TL, Scherzinger A, Stamm E, McDuffie R, Bischoff KJ, Hamman RF, Dabelea D. The long-term impact of intrauterine growth restriction in a diverse U.S. cohort of children: the EPOCH study. Obesity (Silver Spring). 2014 Feb;22(2):608-15. doi: 10.1002/oby.20565. Epub 2013 Sep 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Reznik, MD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Epigenetics, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth velocity (time frame: Until 24 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402139, which also lists 63 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.