Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-04 @ 7:56 PM
Study NCT ID:
NCT07159594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigator not taking part of the intervention will provide randomisation to start with diet or control'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Intervention with delayed intervention in the control arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walking test', 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Lung function', 'timeFrame': '20 weeks', 'description': 'FEV₁ (Forced Expiratory Volume in 1 second)\n\nFVC (Forced Vital Capacity)\n\nFEV₁/FVC ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Obesity &Amp; Overweight']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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:\n\nPrimary outcome:\n\n-Exercise capacity (6-minute walking test).\n\nSecondary outcomes:\n\n-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).\n\nA subgroup will also undergo sputum analysis.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT07159594', 'briefTitle': 'The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD', 'orgStudyIdInfo': {'id': 'SahlgrenskaUH03610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Energy restriction', 'description': 'One arm will start as control group', 'interventionNames': ['Other: Energy restriction']}, {'type': 'OTHER', 'label': 'Energy restriction delayed', 'description': 'delayed', 'interventionNames': ['Other: Energy restriction']}], 'interventions': [{'name': 'Energy restriction', 'type': 'OTHER', 'otherNames': ['Energy restriction delayed'], 'description': 'Diet with LED and energy restricted diet with gradually inclusion of meals', 'armGroupLabels': ['Energy restriction', 'Energy restriction delayed']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jenny van Odijk, Docent', 'role': 'CONTACT', 'email': 'jenny.vanodijk@nutrition.gu.se', 'phone': '+46076-6183709'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will be added later'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Docent', 'investigatorFullName': 'Jenny van Odijk', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}