COPDNCT07159594
The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD
A study testing Energy restriction in people with COPD and Obesity &Amp; Overweight, run by Sahlgrenska University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Obesity &Amp; Overweight
- What is being tested?
- Energy restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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
- Being tested
- Energy restriction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy restrictionOther
Also called Energy restriction delayed
Diet with LED and energy restricted diet with gradually inclusion of meals
| Study group | Role | What they receive |
|---|---|---|
| Energy restriction | Other | One arm will start as control group Receives: Other: Energy restriction |
| Energy restriction delayed | Other | delayed Receives: Other: Energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking test
Measured: 20 weeks
Secondary outcomes (1)
Lung function
FEV₁ (Forced Expiratory Volume in 1 second)
FVC (Forced Vital Capacity)
FEV₁/FVC ratio
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Intervention with delayed intervention in the control arm
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Jenny van Odijk, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159594
- Sponsor's protocol ID
- SahlgrenskaUH03610
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be added later
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD
- ClinicalTrials.gov ID
- NCT07159594
- Acronym / sponsor ID
- SahlgrenskaUH03610
- Conditions
- COPD, Obesity &Amp; Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention with delayed intervention in the control arm
| Arm | Type | Receives |
|---|---|---|
| Energy restriction | Other | Other: Energy restrictionOne arm will start as control group |
| Energy restriction delayed | Other | Other: Energy restrictiondelayed |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy restrictionAlso: Energy restriction delayedDiet with LED and energy restricted diet with gradually inclusion of meals | Other | Energy restriction, Energy restriction delayed |
Primary outcome
6 minute walking test
Time frame: 20 weeks
1 secondary outcome
Lung function
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided. Will be added later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Energy restriction in people with COPD and Obesity &Amp; Overweight, run by Sahlgrenska University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny van Odijk, Docent (+46076-6183709, jenny.vanodijk@nutrition.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walking test (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.