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

NCT07663591 | Not Yet Recruiting

• 1 other identifier: 2026ML
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity (BMI>30)

Outcome Measures

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.

  Baseline to 3 months

Secondary Outcomes (19)

• Maximum Expiratory Pressure (MEP)

  Baseline to 3 months

• Forced vital capacity (FVC)

  Baseline to 3 months

• Forced expiratory volume in the first second (FEV1)

  Baseline to 3 months

• FEV1/FVC

  Baseline to 3 months

• Respiratory Muscle Endurance

  Baseline to 3 months

Interventions

Incretin-based therapy OTHER

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.

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with obesity using incretin based therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Şafak Yiğit, PhD

CONTACT

+90 5309634910; safakyigit90@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 30, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-06