Machine Learning Prediction of Respiratory Muscle Changes and Ventilatory Responses After Incretin-Based Therapy in Obesity
17 de junio de 2026 actualizado por: Buket AKINCI, Biruni University
Prediction of Changes in Pulmonary Function, Respiratory Muscle Performance, and Ventilatory Responses Following Incretin-Based Therapy in Individuals With Obesity Using Machine Learning
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
48
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Şafak Yiğit, PhD
- Número de teléfono: +90 5309634910
- Correo electrónico: safakyigit90@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Individuals with obesity using incretin based therapy
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
Charlson Comorbidity Index (CCI) score ≥ 3 Uncontrolled arrhythmia, hypertension, heart failure, diabetes mellitus, or unstable angina pectoris Cognitive, orthopedic, or neurological conditions that may interfere with study assessments or treatment procedures History of lower extremity injury or surgery within the previous 6 months Diagnosis of diabetes mellitus with complications such as nephropathy, retinopathy, or neuropathy Presence of chronic respiratory disease Acute infection at the time of assessment Middle ear pathologies (e.g., tympanic membrane rupture or otitis) History of spontaneous or traumatic pneumothorax Current smoking Pregnancy STOP-Bang score ≥ 3 Participation in a structured weight-loss diet program or receipt of medical treatment for weight reduction during the assessment period History of endoscopic weight-loss procedures and/or bariatric surgery within the previous 12 months
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Inspiratory Pressure (MIP)
Periodo de tiempo: Baseline to 3 months
|
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.
|
Baseline to 3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum Expiratory Pressure (MEP)
Periodo de tiempo: Baseline to 3 months
|
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.
|
Baseline to 3 months
|
|
Forced vital capacity (FVC)
Periodo de tiempo: Baseline to 3 months
|
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.
|
Baseline to 3 months
|
|
Forced expiratory volume in the first second (FEV1)
Periodo de tiempo: Baseline to 3 months
|
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.
|
Baseline to 3 months
|
|
FEV1/FVC
Periodo de tiempo: Baseline to 3 months
|
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.
|
Baseline to 3 months
|
|
Respiratory Muscle Endurance
Periodo de tiempo: Baseline to 3 months
|
Participants' respiratory muscle endurance will be assessed using an inspiratory muscle training device (POWERbreathe® K-SerieS-K3, POWERbreathe International Ltd, UK).
Measurements will be taken in a seated position with the device placed in the mouth using a nose clip.
The assessment will be conducted using an increasing threshold loading protocol.
At the start of the test, the threshold pressure will be set to 20% of the individual's MIP (maximum inspiratory pressure).
The individual will be asked to breathe 30 times over two minutes.
Individuals who tolerate this level will proceed to the next step, gradually increasing the pressure to 40%, 60%, 80%, and 100% respectively.
Oxygen saturation and pulse rate will be recorded before and after the test using a pulse oximeter.
|
Baseline to 3 months
|
|
Functional capacity
Periodo de tiempo: Baseline to 3 months
|
Participants' exercise capacity will be assessed using the Spiropalm 6MWT (Cosmed, Italy) six-minute walk test (6MWT) according to American Thoracic Society (ATS) criteria.
This device is a comprehensive system that includes an integrated pulse oximeter for monitoring oxygen saturation during the test and allows for measurement of heart rate, minute ventilation (VE), and respiratory pattern during walking.
The Spiropalm 6MWT meets all technical criteria set by the ATS for the 6MWT and is also compliant with ATD/ASD spirometry standards.
The test will be conducted in a 30-meter straight corridor in an enclosed area.
Participants will rest for at least 10 minutes before starting the test.
Following the rest period, heart rate, blood pressure, and oxygen saturation measurements will be taken.
In addition, dyspnea and leg fatigue levels will be assessed using the Modified Borg Scale (0-10).
Participants will be asked to walk at a pace faster than their normal walking
|
Baseline to 3 months
|
|
Ventilation (VE)
Periodo de tiempo: Baseline to 3 months
|
During the 6MWT will be measured using a Spiropalm device.
|
Baseline to 3 months
|
|
Peak respiratory reserve (BRpeak)
Periodo de tiempo: Baseline to 3 months
|
During the 6MWT, peak respiratory reserve (BRpeak) will be measured using a Spiropalm device.
|
Baseline to 3 months
|
|
Peak ventilation (VEpeak)
Periodo de tiempo: Baseline to 3 months
|
During the 6MWT, peak ventilation (VEpeak) will be measured using a Spiropalm device.
|
Baseline to 3 months
|
|
Inspiratory capacity (IC)
Periodo de tiempo: Baseline to 3 months
|
During the 6MWT, inspiratory capacity (IC) will be measured using a Spiropalm device.
|
Baseline to 3 months
|
|
Waist Index (WI) Adjusted for Weight
Periodo de tiempo: Baseline to 3 months
|
This will be calculated according to the following formula based on waist circumference and weight measurements.
|
Baseline to 3 months
|
|
Skeletal Muscle Mass Index (SMMI)
Periodo de tiempo: Baseline to 3 months
|
Skeletal Muscle Mass Index (SMMI) is calculated by dividing an individual's total skeletal muscle mass (kg) by the square of their height in meters (m²) (kg/m²).
|
Baseline to 3 months
|
|
Body Roundness Index (BRI)
Periodo de tiempo: Baseline to 3 months
|
The Body Roundness Index (BRI) will be calculated using the individual's waist circumference (cm) and height (m) according to the standard formula defined in the literature.
The BRI value will be evaluated as an indicator of body fat distribution and abdominal obesity level.
|
Baseline to 3 months
|
|
Body muscle mass
Periodo de tiempo: Baseline to 3 months
|
Participants' body muscle mass (kg) and body muscle percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Individuals will be informed about the test protocol and instructed to fast for 8-12 hours before the measurement, to arrive with an empty bladder, and to avoid fluids, food, and strenuous physical activity.
Measurements will be taken at a room temperature of 25°C, during the daytime, and participants will be asked to remove their shoes, socks, and all metal objects before stepping onto the device barefoot.
|
Baseline to 3 months
|
|
Body fat mass
Periodo de tiempo: Baseline to 3 months
|
Participants' body fat mass (kg), body fat percentage (%) will be measured using Bioelectrical Impedance Analysis (BIA).
Individuals will be informed about the test protocol and instructed to fast for 8-12 hours before the measurement, to arrive with an empty bladder, and to avoid fluids, food, and strenuous physical activity.
Measurements will be taken at a room temperature of 25°C, during the daytime, and participants will be asked to remove their shoes, socks, and all metal objects before stepping onto the device barefoot.
|
Baseline to 3 months
|
|
Waist circumference
Periodo de tiempo: Baseline to 3 months
|
Waist circumference will be measured with a non-stretch measuring tape.
The measurement will be taken three times at the level of the navel with the patient in an upright position during exhalation, with both feet bearing equal weight.
The average value will be recorded in centimeters (cm).
|
Baseline to 3 months
|
|
Daily step count
Periodo de tiempo: Baseline to 3 months
|
Participants' physical activity levels will be assessed using a wearable activity monitor.
The device uses a six-axis sensor (accelerometer and gyroscope) to temporarily store data on the user's lifestyle and physical activity profile in its memory for the duration of wear.
The wearable activity monitor will track participants' daily step counts.
Participants will be asked to wear the activity monitor continuously on their left wrist for at least 72 hours, excluding sleep or bathing hours.
|
Baseline to 3 months
|
|
Fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c)
Periodo de tiempo: Baseline to 3 months
|
For the glucose profile of participants after 12 hours of fasting, fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1c) levels will be measured.
|
Baseline to 3 months
|
|
Lipid profile
Periodo de tiempo: Baseline to 3 months
|
Participants will have their lipid profile measured after a 12-hour fast, including high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, and triglyceride levels.
|
Baseline to 3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
30 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026ML
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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