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NCT Number: NCT07159594

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy restriction

Other

Diet with LED and energy restricted diet with gradually inclusion of meals

Other names: Energy restriction delayed

Primary outcomes

  1. 6 minute walking test

    Time frame: 20 weeks

Secondary outcomes

  1. Lung function

    Time frame: 20 weeks

    FEV₁ (Forced Expiratory Volume in 1 second)

    FVC (Forced Vital Capacity)

    FEV₁/FVC ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny van Odijk, Docent

CONTACT

[email protected]

+46076-6183709

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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