Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT01015794
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2009-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004809', 'term': 'Ephedrine'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2009-10-29', 'studyFirstSubmitQcDate': '2009-11-17', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BAT activity via PET-CT', 'timeFrame': 'Baseline and 3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '23064293', 'type': 'RESULT', 'citation': 'Carey AL, Formosa MF, Van Every B, Bertovic D, Eikelis N, Lambert GW, Kalff V, Duffy SJ, Cherk MH, Kingwell BA. Ephedrine activates brown adipose tissue in lean but not obese humans. Diabetologia. 2013 Jan;56(1):147-55. doi: 10.1007/s00125-012-2748-1. Epub 2012 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators aim to quantitate the extent of cervical and upper thoracic brown adipose tissue (BAT) activation in lean and obese humans via positron emission tomography-computed tomography (PET-CT) in response to the non-specific beta adrenergic receptor (AR) agonist ephedrine. The investigators hypothesise that this pharmacological adrenergic stimulus will result in activation of BAT in these participants, and that this activation will be reduced in obese patients. This study will provide important preliminary information with respect to allowing the investigators to progress with longer trials with specific beta 3 AR agonists.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: healthy group\n\n* Males aged 20 - 40 years\n* Free of overt coronary disease (on history, medical examination and ECG)\n* Fasting plasma glucose \\< 6.1 mmol/L and 2 hour OGTT glucose \\< 7.8 mmol/L\n* Unmedicated\n* No major illness\n* BMI 18 - 25\n\nInclusion Criteria: obese group\n\n* Males aged 20 - 40 years\n* Free of overt coronary disease (on history, medical examination and ECG)\n* Unmedicated\n* No major illness\n* BMI 30+\n* Weight \\< 100 kg\n* Height \\< 185 cm\n\nThe inclusion criteria (Obese participants) of body weight less than \\~100 kg is implemented as the PET-CT scanner to be utilised (protocol described subsequently) has a limited patient volume. Therefore to fit within the criteria of BMI \\> 30, only patients of height \\~183 cm or less can be recruited, and inclusion of borderline participants will be discussed with co-investigators from the Alfred Hospital Nuclear Medicine Department.\n\nExclusion Criteria: healthy group\n\n* Unable to give informed consent\n* Smokers\n* Lactose intolerance\n\nExclusion Criteria: obese group\n\n* Unable to give informed consent\n* Smokers\n* Lactose intolerance\n* Participant in research projects involving ionising radiation within the past 5 years\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT01015794', 'briefTitle': 'Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'Activation of Cervical and Upper Thoracic Brown Adipose Tissue in Humans Via Beta-adrenergic Stimulation', 'orgStudyIdInfo': {'id': '404/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adrenergic agonist', 'interventionNames': ['Drug: ephedrine hydrochloride']}], 'interventions': [{'name': 'ephedrine hydrochloride', 'type': 'DRUG', 'description': 'single oral dose, 1mg/kg body weight', 'armGroupLabels': ['Adrenergic agonist']}, {'name': 'ephedrine hydrochloride', 'type': 'DRUG', 'description': 'single dose of 1 mg/kg body weight', 'armGroupLabels': ['Adrenergic agonist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital Heart Centre', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}