Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-20 @ 11:33 AM
Study NCT ID:
NCT02500004
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2015-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'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': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D002153', 'term': 'Calorimetry, Indirect'}, {'id': 'D061725', 'term': 'Accelerometry'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002151', 'term': 'Calorimetry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brown adipose tissue (BAT) activity measured by PET(-MRI)', 'timeFrame': 'participants will be followed for 2 weeks', 'description': 'The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning.'}], 'secondaryOutcomes': [{'measure': 'Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water', 'timeFrame': 'participants will be followed for 2 weeks'}, {'measure': 'Resting metabolic rate measured by REE', 'timeFrame': 'participants will be followed for 2 weeks'}, {'measure': 'Metabolic gene expression in WAT measured by biopsy of subcutaneous fat', 'timeFrame': 'participants will be followed for 2 weeks'}, {'measure': 'Systemic inflammatory status measured in blood', 'timeFrame': 'participants will be followed for 2 weeks'}, {'measure': 'Fat tissue mass measured by MRI, DXA, and doubly labeled water', 'timeFrame': 'participants will be followed for 2 weeks', 'description': 'Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)'}, {'measure': 'Hormonal status measured in blood', 'timeFrame': 'participants will be followed for 2 weeks'}, {'measure': 'Lean tissue mass measured by MRI, DXA, and doubly labeled water', 'timeFrame': 'participants will be followed for 2 weeks', 'description': 'Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cachexia', 'Neoplasms', 'Pulmonary Disease, Chronic Obstructive', 'Pancreatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '33550302', 'type': 'DERIVED', 'citation': 'Sanders K, Klooster K, Vanfleteren LEGW, Plasqui G, Dingemans AM, Slebos DJ, Schols AMWJ. Effect of Bronchoscopic Lung Volume Reduction in Advanced Emphysema on Energy Balance Regulation. Respiration. 2021 Feb 5:1-8. doi: 10.1159/000511920. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.', 'detailedDescription': 'This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients\n* The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index \\< 20 kg/m2 and muscle wasting assessed by DXA;\n* Age ≥ 30 years;\n* Gender: male and female;\n* Caucasians.\n\nExclusion Criteria:\n\n* Uncontrolled Diabetes Mellitus;\n* Patients with severe clotting disorder;\n* Patients with an active second malignancy;\n* Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia;\n* Persons unable to lie or sit still for 1-2 hours;\n* Oxygen therapy;\n* Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets);\n* Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history;\n* Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves;\n* The use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).'}, 'identificationModule': {'nctId': 'NCT02500004', 'acronym': 'BAT-Cachexia', 'briefTitle': 'Brown Adipose Tissue Activity and Energy Metabolism in Cachexia', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease', 'orgStudyIdInfo': {'id': '142071'}, 'secondaryIdInfos': [{'id': 'NL51402.068.14', 'type': 'OTHER', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cachectic pancreatic cancer', 'description': 'Cachectic patients with pancreatic cancer\n\nBAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.\n\nSystemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.', 'interventionNames': ['Radiation: 18F-FDG PET-MRI-imaging', 'Radiation: DXA scanning', 'Procedure: Abdominal subcutaneous adipose tissue biopsy', 'Procedure: Blood sampling', 'Other: Indirect calorimetry', 'Device: Accelerometry', 'Other: Double-labeled water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cachectic NSCLC', 'description': 'Cachectic patients with non-small cell lung cancer\n\nBAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.\n\nSystemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.', 'interventionNames': ['Radiation: 18F-FDG PET-MRI-imaging', 'Radiation: DXA scanning', 'Procedure: Abdominal subcutaneous adipose tissue biopsy', 'Procedure: Blood sampling', 'Other: Indirect calorimetry', 'Device: Accelerometry', 'Other: Double-labeled water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cachectic COPD', 'description': 'Cachectic COPD patients.\n\nBAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.\n\nSystemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.', 'interventionNames': ['Radiation: 18F-FDG PET-MRI-imaging', 'Radiation: DXA scanning', 'Procedure: Abdominal subcutaneous adipose tissue biopsy', 'Procedure: Blood sampling', 'Other: Indirect calorimetry', 'Device: Accelerometry', 'Other: Double-labeled water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-cachectic COPD', 'description': 'Non-cachectic COPD patients.\n\nBAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.\n\nSystemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.', 'interventionNames': ['Radiation: 18F-FDG PET-MRI-imaging', 'Radiation: DXA scanning', 'Procedure: Abdominal subcutaneous adipose tissue biopsy', 'Procedure: Blood sampling', 'Other: Indirect calorimetry', 'Device: Accelerometry', 'Other: Double-labeled water']}, {'type': 'OTHER', 'label': 'Healthy individuals', 'description': 'BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.\n\nSystemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.', 'interventionNames': ['Radiation: 18F-FDG PET-MRI-imaging', 'Radiation: DXA scanning', 'Procedure: Abdominal subcutaneous adipose tissue biopsy', 'Procedure: Blood sampling', 'Other: Indirect calorimetry', 'Device: Accelerometry', 'Other: Double-labeled water']}], 'interventions': [{'name': '18F-FDG PET-MRI-imaging', 'type': 'RADIATION', 'description': 'BAT activity: 18F-FDG PET-MRI-imaging.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}, {'name': 'DXA scanning', 'type': 'RADIATION', 'description': 'Body composition: DXA scanning, D2O and MRI.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}, {'name': 'Abdominal subcutaneous adipose tissue biopsy', 'type': 'PROCEDURE', 'description': 'Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}, {'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Systemic inflammatory profile: blood sampling.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}, {'name': 'Indirect calorimetry', 'type': 'OTHER', 'description': 'Resting metabolic rate: indirect calorimetry.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}, {'name': 'Accelerometry', 'type': 'DEVICE', 'description': 'Physical activity level: accelerometry.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}, {'name': 'Double-labeled water', 'type': 'OTHER', 'description': 'Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.', 'armGroupLabels': ['Cachectic COPD', 'Cachectic NSCLC', 'Cachectic pancreatic cancer', 'Healthy individuals', 'Non-cachectic COPD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Annemie Schols, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}