Machine Learning Prediction of Respiratory Muscle Changes and Ventilatory Responses After Incretin-Based Therapy in Obesity
2026年6月17日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
48
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Şafak Yiğit, PhD
- 電話番号：+90 5309634910
- メール：safakyigit90@gmail.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Individuals with obesity using incretin based therapy
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Inspiratory Pressure (MIP)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Expiratory Pressure (MEP)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Baseline to 3 months
|
During the 6MWT will be measured using a Spiropalm device.
|
Baseline to 3 months
|
|
Peak respiratory reserve (BRpeak)
時間枠：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)
時間枠：Baseline to 3 months
|
During the 6MWT, peak ventilation (VEpeak) will be measured using a Spiropalm device.
|
Baseline to 3 months
|
|
Inspiratory capacity (IC)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
|
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年7月1日
研究の完了 (推定)
2026年7月30日
試験登録日
最初に提出
2026年6月17日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。