Machine Learning Prediction of Respiratory Muscle Changes and Ventilatory Responses After Incretin-Based Therapy in Obesity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-60
SponsorBiruni University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Incretin-based therapy

    Other intervention

    This 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 3 months

Secondary outcomes

1

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.

Time frame
Baseline to 3 months
2

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.

Time frame
Baseline to 3 months
3

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.

Time frame
Baseline to 3 months
4

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.

Time frame
Baseline to 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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