Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence

Obesity Clinical Trial

Official title:

Obesity-asthma Endophenotype: Assessment of Diaphragm Mobility and Muscle Inflammation Markers in the Adolescence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029936
• Other study ID #: 43599215.4.0000.5208
• Status: Completed
• First received: January 19, 2017
• Last updated: March 16, 2018
• Start date: July 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Obesity

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm mobility	Change in "mm" of diaphragm mobility.	1 day
Secondary	Diaphragm thickness	Change in "cm" of diaphragm thickness.	1 day
Secondary	Th1 Cytokine Levels	Change in "pg/mL" of Th1 Cytokines	1 day
Secondary	Th2 Cytokine Levels	Change in "pg/mL" of Th2 Cytokines	1 day