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Completed

NCT Number: NCT03029936

Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence

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.

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Key information

Conditions

Obesity Asthma Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diaphragm mobility

    Time frame: 1 day

    Change in "mm" of diaphragm mobility.

Secondary outcomes

  1. Diaphragm thickness

    Time frame: 1 day

    Change in "cm" of diaphragm thickness.

  2. Th1 Cytokine Levels

    Time frame: 1 day

    Change in "pg/mL" of Th1 Cytokines

  3. Th2 Cytokine Levels

    Time frame: 1 day

    Change in "pg/mL" of Th2 Cytokines

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2017
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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