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

NCT07159594 | Not Yet Recruiting

• 1 other identifier: SahlgrenskaUH03610
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD; Obesity &Amp; Overweight

Outcome Measures

Primary Outcomes (1)

• 6 minute walking test

  20 weeks

Secondary Outcomes (1)

• Lung function

  20 weeks

Study Arms (2)

Energy restriction

OTHER

One arm will start as control group

Other: Energy restriction

Energy restriction delayed

OTHER

delayed

Other: Energy restriction

Interventions

Energy restriction OTHER

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

Also known as: Energy restriction delayed

Energy restriction; Energy restriction delayed

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity; Overweight

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Central Study Contacts

Jenny van Odijk, Docent

CONTACT

+46076-6183709; jenny.vanodijk@nutrition.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigator not taking part of the intervention will provide randomisation to start with diet or control
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent

Model Details: Intervention with delayed intervention in the control arm

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08