Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-04-22 @ 1:11 AM
Study NCT ID:
NCT03096535
Status:
COMPLETED
Last Update Posted:
2018-03-26
First Post:
2017-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cold Induced Activation of Brown Adipose Tissue in Humans
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'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064590', 'term': 'Cool-Down Exercise'}], 'ancestors': [{'id': 'D000096063', 'term': 'Post-Exercise Recovery Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in brown adipose tissue (BAT) activity after cooling versus no cooling.', 'timeFrame': 'Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.', 'description': 'BAT activity is measured by standard fluorodeoxyglukose uptake volume (SUV mean) in the supraclavicular BAT depot using PET/MR scans. Difference between scans performed after 2 hours of cooling and 2 hours of no cooling is calculated.'}], 'secondaryOutcomes': [{'measure': 'Difference in BAT activity after cooling versus no cooling.', 'timeFrame': 'Difference in peak temperature after 2 hours of cooling versus 2 hours of no cooling.', 'description': 'BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 2 hours of cooling and 2 hours of no cooling is calculated.'}, {'measure': 'Difference in resting energy expenditure after cooling versus no cooling', 'timeFrame': 'Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.', 'description': 'Difference in resting energy expenditure after cooling versus no cooling, measured as mean difference in KJ/min.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adipose Tissue, Brown', 'Brown Adipose Tissue', 'Brown Fat', 'Uncoupling Protein 1', 'Adipokines', 'Proteomics', 'Infrared Thermography', 'BAT', 'Obesity', 'Type 2 Diabetes', 'Proteins']}, 'referencesModule': {'references': [{'pmid': '34755128', 'type': 'DERIVED', 'citation': 'Soberg S, Lofgren J, Philipsen FE, Jensen M, Hansen AE, Ahrens E, Nystrup KB, Nielsen RD, Solling C, Wedell-Neergaard AS, Berntsen M, Loft A, Kjaer A, Gerhart-Hines Z, Johannesen HH, Pedersen BK, Karstoft K, Scheele C. Altered brown fat thermoregulation and enhanced cold-induced thermogenesis in young, healthy, winter-swimming men. Cell Rep Med. 2021 Oct 11;2(10):100408. doi: 10.1016/j.xcrm.2021.100408. eCollection 2021 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates cold-induced brown fat activation assessed using PET/MR scans. Subjects will participate in an acute cooling intervention day and a thermoneutral intervention day with PET/MR scans on both days. A secondary purpose is to make a validation of an infrared thermography camera by comparison of skin temperatures and SUV of the supraclavicular brown adipose tissue.', 'detailedDescription': 'The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood and even less is known about the endocrine capacities of human BAT.\n\nCold induced brown fat activity will be assessed with PET/MR scans and validate an infra-red thermography camera, as well as perform a proteomic screening using blood samples under these two intervention days.\n\n15 healthy lean male subjects will serve as their own control in a cross-over randomized control study, including a pre-examination day, a thermoneutral-day and a cooling test-day with cold exposure followed by a PET/MR scan to determine BAT activity. An extra cooling day is applied for the external validation of the infrared thermography camera. Blood samples and abdominal fat-biopsies will be taken at thermoneutral condition and under cold stimulation of brown fat.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-30 years.\n* Men\n* Caucasian white\n* Body Mass Index 19-25 kg/m2.\n* Moderate physical activity level (not more than 8-10 hours of training pr. Week)\n* Ability to give informed consent.\n* Ability to follow verbal and written instructions in Danish.\n* Body fat percent under 21% measured at the pre-examination day.\n\nExclusion Criteria:\n\n* Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.\n* Tobacco, marijuana or intravenous drug use within 1 year of screening.\n* Dieting, recent weight loss (\\>3 kg within 3 month) or a history of an eating disorder.\n* Dietary supplements.\n* History of depression, psychosis, or other psychiatric illness requiring hospitalization.\n* Alcohol consumption \\>14 units/week.\n* History of alcohol abuse within the past 3 years.\n* Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.\n* Known kidney disease or elevated kidney biomarkers, eCRF \\<60 ml/min, in the preliminary investigation.\n* Use of daily medications, except for seasonal use of antihistamines.\n* Diagnosed sleep disturbances.\n* Pacemaker or other electronics implanted in the body.\n* Magnetic impressionable metal implants or foreign objects in the body inconsistent with completion of MR.\n* Claustrophobia\n* Communication problems, including understanding the experimental protocol\n* History of contrast allergy.\n* Winter swimmers.'}, 'identificationModule': {'nctId': 'NCT03096535', 'acronym': 'COLDBAT', 'briefTitle': 'Cold Induced Activation of Brown Adipose Tissue in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cold Induced Activation of Brown Fat in Humans Assessed With PET/MR Scans and Skin-temperature Measure - A Cross-over Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'H-16038581-COLDBAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cooling', 'description': 'Individualized cooling protocol.', 'interventionNames': ['Procedure: Cooling']}, {'type': 'EXPERIMENTAL', 'label': 'Thermoneutral', 'description': 'Thermoneutral condition day.', 'interventionNames': ['Procedure: Thermoneutral']}], 'interventions': [{'name': 'Cooling', 'type': 'PROCEDURE', 'otherNames': ['Cold activation', 'Cold stimulation', 'Cold activation of BAT'], 'description': 'Individualized cooling protocol.', 'armGroupLabels': ['Cooling']}, {'name': 'Thermoneutral', 'type': 'PROCEDURE', 'description': 'Thermoneutral control day.', 'armGroupLabels': ['Thermoneutral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Inflammation and Metabolism/ Center for Physical Activity Research', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Susanna Søberg, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Inflammation and Metabolism/Center for physical activity research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Susanna Søberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Susanna Søberg', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}