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

Sahlgrenska University Hospital

Status: Not yet enrolling

Conditions: Obesity &Amp; Overweight; COPD

Treatments: Other: Energy restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT07159594

SahlgrenskaUH03610

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Energy restriction

Other group

Description:

One arm will start as control group

Treatment:

Other: Energy restriction

Energy restriction delayed

Other group

Description:

delayed

Treatment:

Other: Energy restriction