Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT01985503
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Follow-up of Brown Adipose Tissue Function and Structure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples, fecal samples, adipose tissue biopsies and skeletal muscle biopsies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 95}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-08', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between baseline brown adipose tissue activity according to PET imaging and serum lipoprotein concentrations at follow-up 5 years later', 'timeFrame': '5 years', 'description': "Brown adipose tissue activity is determined with FDG-PET imaging at baseline in 43 subjects and 5 years later the subjects participate a follow-up visit where lipoprotein levels are measured in mmol/l from serum samples. Correlation between brown adipose tissue activity and serum lipoproteins are examined with Pearson's correlation."}], 'secondaryOutcomes': [{'measure': 'Association between brown adipose tissue structure at baseline and at follow-up', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['positron emission tomography', 'magnetic resonance imaging', 'brown adipose tissue', 'obesity', 'cardiovascular disease', 'subclinical atherosclerosis'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up study to examine associations between obesity, cardiovascular risk factors, serum metabolic profile and BAT structure at baseline and during follow-up several years later. 43 BATPET participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52 FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years. The aim of this study is to examine longitudinal associations between BAT function and structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study subjects are healthy 22-55-year-old Caucasians. Population contains both lean and obese subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All study subjects have been screened prior to acceptance in BATPET, FATBAT and Dixon-BAT studies and no screening for inclusion is required in the current study.\n\nExclusion Criteria:\n\n* 1\\) Smoking 2) Blood pressure \\> 160/100 mmHg 3) Pregnancy or lactation 4) Medication (expected effect on study variables)'}, 'identificationModule': {'nctId': 'NCT01985503', 'acronym': 'BATFollowUp', 'briefTitle': 'Longitudinal Follow-up of Brown Adipose Tissue Function and Structure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Brown Adipose Tissue: Longitudinal Follow-up of Brown Adipose Tissue Structure and Associations With Obesity and Cardiovascular Risk Factors in Healthy Participants of Baseline PET Studies (BAT-Follow-Up)', 'orgStudyIdInfo': {'id': 'BAT-Follow-Up'}, 'secondaryIdInfos': [{'id': 'BATFOLLOWUP', 'type': 'OTHER', 'domain': 'PET Centre, Turku University'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1 group', 'description': 'Subjects were studied in 2009 and their follow-up is in 2014.'}, {'label': 'Phase 2 group', 'description': 'Subjects were studied in 2011 and their follow-up is in 2016.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'PET Centre, Turku University', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Juho RH Raiko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PET Centre, Turku Univesity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Juho Raiko', 'investigatorAffiliation': 'Turku University Hospital'}}}}