About this trial
This study aims to evaluate changes in respiratory function, respiratory muscle performance, and ventilatory responses following incretin-based therapy in individuals with obesity, and to identify predictors of these changes through the application of machine learning methods.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals aged 25-60 years
Individuals with a body mass index (BMI) ≥ 30 kg/m² according to the World - Health Organization (WHO) classification of obesity
Individuals who voluntarily agree to participate in the study
Disqualifiers
None
Trial population
Individuals with obesity using incretin based therapy
Trial design
Cohort
Prospective
Treatments tested in this trial
Incretin-based therapy
Other interventionThis study is a secondary analysis of data obtained from individuals with obesity who received incretin-based therapy in routine clinical practice. No study-specific intervention was assigned by the investigators.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Inspiratory Pressure (MIP)
Maximum inspiratory pressure (MIP) assessment will be performed using an intraoral pressure measuring device (MicroRPM, Micro Medical; UK) in accordance with ATS and ERS criteria. Measurements will be taken with a nasal clip in place and in a seated position. To prevent the risk of infection, a disposable mouthpiece and filter will be used for each participant. For maximum inspiratory pressure (MIP) measurement, maximal inspiration will be applied orally for a few seconds and the values will be recorded. Measurements will be repeated three times, and the best value that meets the measurement standard will be recorded in cmH2O. For the measurement to be considered valid, the difference between the two highest measurements must be less than 10%. When evaluating inspiratory muscle strength, age and gender-specific reference ranges will be considered. The reference equations developed by Black and Hyatt will be used in the interpretation of the measurements.
Secondary outcomes
Maximum Expiratory Pressure (MEP)
Maximum expiratory pressure (MEP) will be measured using an intraoral pressure measuring device (MicroRPM, Micro Medical; UK) in accordance with ATS and ERS criteria. Measurements will be performed with a nasal clip in place and in a seated position. To prevent the risk of infection, a disposable mouthpiece and filter will be used for each participant. Maximum expiratory pressure (MEP) will be measured by applying maximal exhalation for a few seconds and recording the values. Measurements will be repeated three times, and the best value that meets the measurement standard will be recorded in cmH2O. For the measurement to be considered valid, the difference between the two highest measurements must be less than 10%. When evaluating respiratory muscle strength, age and gender-specific reference ranges will be considered. Reference equations developed by Black and Hyatt will be used to interpret the measurements.
Forced vital capacity (FVC)
Forced vital capacity (FVC) will be assessed using pulmonary function tests (PFTs). The assessment will be performed using the "COSMED Spiropalm 6MWT" (COSMED; Italy) device and integrated PFT software, in accordance with ATS and European Respiratory Society (ERS) criteria (ATS\&ERS, 2002). The assessment will be conducted in a seated position with back support. To prevent the risk of infection, a disposable mouthpiece and filter will be used for each participant. Values will be recorded in liters and as a percentage (%) of the expected value. Measurements will be repeated three times, and the best value meeting the measurement standard will be recorded.
Forced expiratory volume in the first second (FEV1)
Forced expiratory volume in the first second (FEV1) will be assessed using pulmonary function tests (PFTs). The assessment will be performed using the "COSMED Spiropalm 6MWT" (COSMED; Italy) device and integrated PFT software, in accordance with ATS and European Respiratory Society (ERS) criteria (ATS\&ERS, 2002). The assessment will be conducted in a seated position with back support. To prevent the risk of infection, a disposable mouthpiece and filter will be used for each participant. Values will be recorded in liters and as a percentage (%) of the expected value. Measurements will be repeated three times, and the best value meeting the measurement standard will be recorded.
FEV1/FVC
FEV1/FVC will be assessed using pulmonary function tests (PFTs), and the assessment will be performed according to ATS and European Respiratory Society (ERS) criteria using the "COSMED Spiropalm 6MWT" (COSMED; Italy) device and integrated PFT software (ATS\&ERS, 2002). The assessment will be performed in a seated position with back support. To prevent the risk of infection, a disposable mouthpiece and filter will be used for each participant. The values will be recorded in liters and as a percentage (%) of the expected value. Measurements will be repeated three times, and the best value that meets the measurement standard will be recorded.
Locations
Sponsors and contacts
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