COPD, Obesity &Amp; Overweight
Conditions
Brief summary
Obesity and COPD are increasingly common and often coexist, worsening health outcomes such as reduced lung function, exercise capacity, and increased systemic inflammation. While COPD was historically associated with underweight, obesity is now more prevalent among these patients and poses new challenges. Despite some evidence that weight loss may improve lung function, comprehensive interventions have not been fully studied. The TRIO-COPD study aims to evaluate a 20-week program combining energy restriction, adequate protein intake, and structured exercise in COPD patients with obesity. The study will assess: Primary outcome: -Exercise capacity (6-minute walking test). Secondary outcomes: -Lung function (spirometry and lung volumes), -symptoms ( assessed via questionnaires), body composition (fat mass, fat-free mass, waist circumference), and inflammatory markers (e.g., IL-6, CRP, CC16). A subgroup will also undergo sputum analysis. The study addresses a critical gap, aiming to determine whether structured weight reduction can improve COPD symptoms, reduce inflammation, and limit muscle loss-advancing understanding of obesity's impact on COPD and providing evidence for potential treatment guidelines.
Interventions
Diet with LED and energy restricted diet with gradually inclusion of meals
Sponsors
Study design
Masking description
Investigator not taking part of the intervention will provide randomisation to start with diet or control
Intervention model description
Intervention with delayed intervention in the control arm
Eligibility
Inclusion criteria
* Individuals with COPD, defined by the GOLD criteria, with a forced expiratory volume in one second (FEV1) \< 80% of predicted and a forced expiratory ratio of \<70, with a BMI ≥ 30 kg/m2
Exclusion criteria
* patients with untreated cardiac disease, renal or hepatic failure, active cancer treatment, diabetes mellitus with prescribed insulin or patients with reported unintentional weight loss in the previous three months, or physical impairment that might affect the exercise capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 minute walking test | 20 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function | 20 weeks | FEV₁ (Forced Expiratory Volume in 1 second) FVC (Forced Vital Capacity) FEV₁/FVC ratio |