Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence

Completed

• Conditions: Asthma; Obesity

• Registration Number: NCT03029936
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Primary Completion: 2017-07-30
• Study Completion: 2017-12-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm mobility	1 day	Change in "mm" of diaphragm mobility.

Secondary Outcome Measures

Name	Time	Method
Diaphragm thickness	1 day	Change in "cm" of diaphragm thickness.
Th1 Cytokine Levels	1 day	Change in "pg/mL" of Th1 Cytokines
Th2 Cytokine Levels	1 day	Change in "pg/mL" of Th2 Cytokines

Trial Locations

Locations (1)

Universidade Federal de Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil