Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02173834
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brown Adipose Tissue and Body Mass Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in sympathetic stimulation to BAT between lean and obese individuals', 'timeFrame': 'Participants will be followed for a mean duration of 2 weeks (the maximal time period between the two scans) The outcome measurements will be assessed when the last subject has been scanned approximately one year after starting the trial'}], 'secondaryOutcomes': [{'measure': 'Difference in correlation between sympathetic stimulation of BAT as assessed with 123I-MIBG SPECT scans and metabolic BAT activity as assessed with 18F-Fluorodeoxyglucose(FDG)- positron emission tomography(PET)-CT scan in lean and obese individuals', 'timeFrame': 'Participants will be followed for a mean duration of 2 weeks (the maximal time period between the two scans) The outcome measurements will be assessed when the last subject has been scanned approximately one year after starting the trial.', 'description': 'The difference in correlation between sympathetic stimulation of BAT and metabolic BAT activity between lean and obese individuals.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brown Adipose Tissue', 'Weight', 'Sympathetic Nervous System'], 'conditions': ['Obesity', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'In this study the investigators aim to investigate whether the sympathetic stimulation of BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between lean and obese individuals, as an explanation for the diminished metabolic brown adipose tissue activity in obese subjects.\n\nThe investigators hypothesis is that sympathetic nervous system activity in the obese is diminished as compared to their leaner counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the obese.', 'detailedDescription': 'The sympathetic nervous system is the primary activator of Brown Adipose Tissue.\n\nObese humans are known to have less metabolically active brown adipose tissue as compared to their leaner counterparts.\n\nThe reason for this diminished metabolic brown adipose tissue activity is unknown.\n\nHowever, a lower sympathetic nervous system activation to brown adipose tissue in the obese might explain a diminished metabolic brown adipose tissue.\n\nTherefore, in this study, both the sympathetic nervous system activation to brown adipose tissue and the metabolic activity will be measured in lean and obese subjects.\n\nsympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine single-photon emission computed tomography scans, metabolic activity will be measured using 18F- fluorodeoxyglucose positron emission tomography CT scans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Caucasian origin\n* Subjects should be able and willing to give informed consent\n* 18-40 years old\n* BMI range of 19-25 kg/m2 (lean study subjects) or 28-40 kg/m2 (obese study subjects)\n\nExclusion Criteria:\n\n* Renal failure (creatinine\\>135mmol/l)\n* Daily use of prescription medication'}, 'identificationModule': {'nctId': 'NCT02173834', 'briefTitle': 'Brown Adipose Tissue and Body Mass Index', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Activation of Brown Adipose Tissue in Lean and Obese Men', 'orgStudyIdInfo': {'id': 'NL41577.018.12 METC 2012.214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lean subjects', 'description': 'Lean, young, healthy, Caucasian, male subjects', 'interventionNames': ['Other: 18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan']}, {'type': 'OTHER', 'label': 'Obese subjects', 'description': 'Obese, Young, Healthy, Caucasian, male subjects', 'interventionNames': ['Other: 18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan']}], 'interventions': [{'name': '18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan', 'type': 'OTHER', 'armGroupLabels': ['Lean subjects', 'Obese subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'F Holleman', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}