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

17 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

48

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Individuals with obesity using incretin based therapy

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum Inspiratory Pressure (MIP)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum Expiratory Pressure (MEP)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline to 3 months
During the 6MWT will be measured using a Spiropalm device.
Baseline to 3 months
Peak respiratory reserve (BRpeak)
Tijdsspanne: 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)
Tijdsspanne: Baseline to 3 months
During the 6MWT, peak ventilation (VEpeak) will be measured using a Spiropalm device.
Baseline to 3 months
Inspiratory capacity (IC)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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Sponsor

Biruni University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

30 juli 2026

Studieregistratiedata

Eerst ingediend

17 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026ML

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

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