Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity

Obesity Clinical Trial

Official title:

Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity: An Epigenetic-mediated Programming of Immune Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903134
• Other study ID #: 13-225
• Secondary ID: FONDECYT 1141195
• Status: Completed
• Start date: September 2014
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study seeks a better understanding of the pathogenesis of asthma in early life. The aim of this project is to determine whether the offspring of obese mothers at 3 years of life have increased the risk of asthma compared to children whose mothers were not obese and whether this increased risk is associated with a programming altered immune reactivity at birth.

Description:

The general objectives of this study are:

1. To determine whether the increased risk of asthma in children born from a pre-pregnant obese mother can be observed at 3 years of life and whether this increased risk associated with altered plasma levels of immune mediators at birth.

2. To explore in children born from pre-pregnant obese mother whether monocyte physiology and M1-M2 polarization present an altered response and expression of asthma-related immune-modulations at birth.

3. To study in neonates born from pre-pregnant obese mother whether the in vitro expression of TNFα, IL12, IL-10 and IL-4Rα in monocytes associates with changes in the DNA methylation status in the promoter regions of those genes.

The study is performed in accordance with the Helsinki Declaration, and the study protocol was accepted by Institutional Review Boards at School of Medicine of the Pontificia Universidad Católica de Chile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women who receive care in any of the 12 public health care centers in La Florida and Puente Alto and give birth in the Sotero del Río Hospital.

• Singleton pregnancy of fewer than 14 weeks of gestation at the first antenatal visit.

• 18 years or older

Exclusion Criteria:

• Pregnant women with overweight (BMI 25-30) before 14 weeks.

• Women that have a premature birth, cardio-respiratory disorder or neurological defects of the neonate.

• Women that develop gestational diabetes and hypertension during pregnancy

Related Conditions & MeSH terms

• Asthma
• Children
• Maternal
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

References & Publications (5)

Castro-Rodriguez JA, Forno E, Casanello P, Padilla O, Krause BJ, Uauy R. Leptin in Cord Blood Associates with Asthma Risk at Age 3 in the Offspring of Women with Gestational Obesity. Ann Am Thorac Soc. 2020 Dec;17(12):1583-1589. doi: 10.1513/AnnalsATS.202 — View Citation

Castro-Rodriguez JA, Forno E, Padilla O, Casanello P, Krause BJ, Borzutzky A. The asthma predictive index as a surrogate diagnostic tool in preschoolers: Analysis of a longitudinal birth cohort. Pediatr Pulmonol. 2021 Jul 28. doi: 10.1002/ppul.25592. [Epu — View Citation

Cifuentes-Zúñiga F, Arroyo-Jousse V, Soto-Carrasco G, Casanello P, Uauy R, Krause BJ, Castro-Rodríguez JA. IL-10 expression in macrophages from neonates born from obese mothers is suppressed by IL-4 and LPS/INF?. J Cell Physiol. 2017 Dec;232(12):3693-3701 — View Citation

Jaramillo-Ospina Á, Castaño-Moreno E, Muñoz-Muñoz E, Krause BJ, Uauy R, Casanello P, Castro-Rodriguez JA. Maternal Obesity Is Associated With Higher Cord Blood Adipokines in Offspring Most Notably in Females. J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2) — View Citation

Vega-Tapia F, Artigas R, Hernández C, Uauy R, Casanello P, Krause BJ, Castro-Rodriguez JA. Maternal obesity is associated with a sex-specific epigenetic programming in human neonatal monocytes. Epigenomics. 2020 Nov;12(22):1999-2018. doi: 10.2217/epi-2020 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)		36 months of age
Secondary	Allergy status (positive skin prick test)		30-36 months of age