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The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD

The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07159594
Enrollment
70
Registered
2025-09-08
Start date
2025-09-01
Completion date
2028-06-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Obesity &Amp; Overweight

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

Göteborg University
CollaboratorOTHER
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frame
6 minute walking test20 weeks

Secondary

MeasureTime frameDescription
Lung function20 weeksFEV₁ (Forced Expiratory Volume in 1 second) FVC (Forced Vital Capacity) FEV₁/FVC ratio

Contacts

Primary ContactJenny van Odijk, Docent
jenny.vanodijk@nutrition.gu.se+46076-6183709

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026