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Not yet recruiting NCT07663591

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

— Observational Obesity (BMI>30)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Incretin-based therapy.
Who it may be relevant to
Registry conditions: Obesity (BMI>30). Basic parameters: 25 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prediction of Changes in Pulmonary Function, Respiratory Muscle Performance, and Ventilatory Responses Following Incretin-Based Therapy in Individuals With Obesity Using Machine Learning

Overview

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.

Interventions

  • Other Incretin-based therapy
    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.

Primary outcome measures

  • Maximum Inspiratory Pressure (MIP) [Time frame: Baseline to 3 months]
Secondary outcome measures (12)
  • Maximum Expiratory Pressure (MEP) [Time frame: Baseline to 3 months]
  • Forced vital capacity (FVC) [Time frame: Baseline to 3 months]
  • Forced expiratory volume in the first second (FEV1) [Time frame: Baseline to 3 months]
  • FEV1/FVC [Time frame: Baseline to 3 months]
  • Respiratory Muscle Endurance [Time frame: Baseline to 3 months]
  • Functional capacity [Time frame: Baseline to 3 months]
  • Ventilation (VE) [Time frame: Baseline to 3 months]
  • Peak respiratory reserve (BRpeak) [Time frame: Baseline to 3 months]
  • Peak ventilation (VEpeak) [Time frame: Baseline to 3 months]
  • Inspiratory capacity (IC) [Time frame: Baseline to 3 months]
  • Waist Index (WI) Adjusted for Weight [Time frame: Baseline to 3 months]
  • Skeletal Muscle Mass Index (SMMI) [Time frame: Baseline to 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07663591 · 2026ML

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗