Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
2. september 2021 oppdatert av: Pontificia Universidad Catolica de Chile
Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity: An Epigenetic-mediated Programming of Immune Function
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.
Studieoversikt
Detaljert beskrivelse
The general objectives of this study are:
- 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.
- 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.
- 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
240
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The recruitment of participants was performed in the Sotero del Rio Hospital at Santiago. Women that were obese (BMI>30) or normal weight (BMI<25) at their first antenatal visit were invited to participate in the study at the moment of delivery.
Questionnaires: Information regarding birth outcomes, maternal and paternal history of asthma and allergy, as well as environmental conditions at home (pet ownership, indoor smoking, heating system, and so on) was collected using a questionnaire at the moment of recruitment.
Follow-up questionnaires by phone are completed every 6 months. These questionnaires collect information regarding diagnosis of asthma/allergy and acute respiratory illness, environmental conditions, and relevant confounding variables
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Newborn from obese and nonobese pregnant
Obese (BMI>30) or normal weight (BMI<25) women at their first antenatal visit were invited to participate in the study at the moment of delivery at Sotero del Rio Hospital, Santiago.
Information regarding birth outcomes, parental history, as well as environmental conditions was collected at recruitment.
Follow-up questionnaires by phone were completed every 6 months.
Umbilical cord blood samples were collected to measure IL-12, TNF-α, IL-10, IL-4; to evaluate metabolic status; to isolated monocytes and macrophage differentiation; and for DNA methylation status of the promoter regions of the genes coding for TNF-α, IL-12, IL-10, and IL-4Rα.
Also, fasting blood samples of the mothers within 48 hours after delivery; and blood samples and skin prick test were collected.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)
Tidsramme: 36 months of age
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36 months of age
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Allergy status (positive skin prick test)
Tidsramme: 30-36 months of age
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30-36 months of age
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jose A. Castro-Rodriguez, MD, PhD, Pontificia Universidad Catolica de Chile
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.202001-080OC.
- Cifuentes-Zuniga F, Arroyo-Jousse V, Soto-Carrasco G, Casanello P, Uauy R, Krause BJ, Castro-Rodriguez JA. IL-10 expression in macrophages from neonates born from obese mothers is suppressed by IL-4 and LPS/INFgamma. J Cell Physiol. 2017 Dec;232(12):3693-3701. doi: 10.1002/jcp.25845. Epub 2017 Apr 27.
- Vega-Tapia F, Artigas R, Hernandez 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-2020-0098. Epub 2020 Dec 4.
- Jaramillo-Ospina A, Castano-Moreno E, Munoz-Munoz 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):264-270. doi: 10.1097/MPG.0000000000003172.
- 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 Oct;56(10):3183-3188. doi: 10.1002/ppul.25592. Epub 2021 Jul 28.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2014
Primær fullføring (Faktiske)
1. april 2018
Studiet fullført (Faktiske)
1. juni 2018
Datoer for studieregistrering
Først innsendt
13. september 2016
Først innsendt som oppfylte QC-kriteriene
15. september 2016
Først lagt ut (Anslag)
16. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2021
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 13-225
- FONDECYT 1141195 (Annet stipend/finansieringsnummer: CONICYT-FONDECYT)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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