ObesityNCT03029936
Obesity-asthma Endophenotype and Diaphragm Mobility in Adolescence
An observational study of Obesity and Asthma, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2016to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 108 adolescents aged 12 years to 21 years will be recruited, of all sexes
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity-asthma Endophenotype: Assessment of Diaphragm Mobility and Muscle Inflammation Markers in the 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.
- Keywords
- obesity, asthma, diaphragm excursion, pulmonary function test
- Medical subject headings
- Obesity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity Group | Not described | |
| Asthma Group | Not described | |
| Obesity-Asthma Group | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm mobility
Change in "mm" of diaphragm mobility.
Measured: 1 day
Secondary outcomes (3)
Diaphragm thickness
Change in "cm" of diaphragm thickness.
Measured: 1 day
Th1 Cytokine Levels
Change in "pg/mL" of Th1 Cytokines
Measured: 1 day
Th2 Cytokine Levels
Change in "pg/mL" of Th2 Cytokines
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jul 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lui-s Henrique Sarmento Tenorio, Universidade Federal de Pernambuco
- Investigators
- Luis H Tenório, MsC, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029936
- Sponsor's protocol ID
- 43599215.4.0000.5208
- Status last verified
- Mar 2018
- First submitted
- 19 Jan 2017
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity-asthma Endophenotype: Assessment of Diaphragm Mobility and Muscle Inflammation Markers in the Adolescence
- ClinicalTrials.gov ID
- NCT03029936
- Acronym / sponsor ID
- 43599215.4.0000.5208
- Keywords
- obesity, asthma, diaphragm excursion, pulmonary function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obesity Group | – | – |
| Asthma Group | – | – |
| Obesity-Asthma Group | – | – |
| Control | – | – |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 108 adolescents aged 12 years to 21 years will be recruited, of all sexes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diaphragm mobility
Time frame: 1 day
Change in "mm" of diaphragm mobility.
3 secondary outcomes
Diaphragm thickness
Time frame: 1 day
Th1 Cytokine Levels
Time frame: 1 day
Th2 Cytokine Levels
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis H Tenório, MsC principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Asthma, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm mobility (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.