Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence

NCT ID: NCT03029936

Last Updated: 2018-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-12-01

Brief Summary

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Obesity and asthma share changes that may begin in the fetal development phase. The endophenotype obesity-asthma presents as main characteristic a pattern of inflammatory response different from the habitual Th2 profile of cytokines. In these obese patients, possible changes in the diaphragm muscle can directly influence the dynamics of pulmonary ventilation significantly.

Due to the importance of the diaphragm in pulmonary ventilation, this study will be performed to verify possible alteration in the excursion and diaphragmatic thickness of adolescents with endophenotype obesity-asthma. In parallel, the possible underlying etiopathogenic substrate of this endophenotype will be explored through the dosing of muscle enzymes and inflammatory cytokines and obesity hormones.

Detailed Description

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Conditions

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Obesity Asthma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Obesity Group

No interventions assigned to this group

Asthma Group

No interventions assigned to this group

Obesity-Asthma Group

No interventions assigned to this group

Control

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adolescents of both sexes, aged 12-21 years;
* For the obesity groups, BMI for gender and age equal to or greater than the 97th percentile;
* Clinical diagnosis of persistent, moderate and severe asthma by a specialist physician and its severity classified according to the GINA (Global Initiative Against Asthma) criteria.

Exclusion Criteria

* Adolescents with a diagnosis of cardiovascular, rheumatic, osteoarticular, neuromuscular or any other disease that limits the safe performance of the tests proposed by the protocol will be excluded; And those who do not agree to participate in the study.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Lui-s Henrique Sarmento Tenorio

Principal Investgator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luis H TenĂ³rio, MsC

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Locations

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Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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43599215.4.0000.5208

Identifier Type: -

Identifier Source: org_study_id

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