Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 6:11 AM
Study NCT ID:
NCT01950520
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2013-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D010869', 'term': 'Pindolol'}, {'id': 'D003620', 'term': 'Dantrolene'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D002110', 'term': 'Caffeine'}, {'id': 'C576188', 'term': 'Qsymia'}, {'id': 'D000077236', 'term': 'Topiramate'}, {'id': 'D010645', 'term': 'Phentermine'}, {'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'C520025', 'term': 'mirabegron'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'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': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chenkong@niddk.nih.gov', 'phone': '301-451-1636', 'title': 'Kong Chen, PhD, MSCI', 'organization': 'NIDDK'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Twelve weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 Low Temperature : Placebo', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1 Low Temperature : Proprannolol', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 1 Low Temperature : Dantrolene', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 1 Low Temperature : Magnesium', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 1 Low Temperature : Pindolol', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 1 High Temperature : Placebo', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 1 High Temperature : Proprannolol', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 1 High Temperature : Dantrolene', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 1 High Temperature : Magnesium', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 1 High Temperature : Pindolol', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Cohort 2 : Placebo', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Cohort 2 : Caffeine', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Cohort 2 : Naltrexone', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Cohort 2 : Qsymia', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Cohort 2 : Topiramate', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Cohort 2 : Phentermine', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Cohort 3 : Placebo', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'Cohort 3 : Mirabegron 50mg', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'Cohort 3 : Mirabegron 200mg', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asymptomatic non-sustained ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter-related asymptomatic uncomplicated right upper extremity superficial venous thrombophlebiti', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncopal episode, likely vasovagal response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right lower lung subcentimeter pleural based nodular density', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incidental PET CT- Right upper lung subcentimeter nodule associated with hypermetabolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incidental PET CT- Nonspecific subpleural nodules', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncopal episode, likely vasovagal response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Feels foggy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Feels edgy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG015', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resting Energy Expenditure at Low Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Chamber temperature will be block randomized with low temperature (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)'}], 'classes': [{'title': 'Placebo Cohort 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.277', 'spread': '0.151', 'groupId': 'OG000'}]}]}, {'title': 'Propranolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.134', 'spread': '0.109', 'groupId': 'OG000'}]}]}, {'title': 'Dantrolene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.300', 'spread': '0.118', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.271', 'spread': '0.126', 'groupId': 'OG000'}]}]}, {'title': 'Pindolol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.165', 'spread': '0.112', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 1: Days 1-17', 'description': "Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold.", 'unitOfMeasure': 'kcal/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1'}, {'type': 'PRIMARY', 'title': 'Resting Energy Expenditure at Low Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)'}], 'classes': [{'title': 'Caffeine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.292', 'spread': '0.123', 'groupId': 'OG000'}]}]}, {'title': 'Phentermine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.217', 'spread': '0.116', 'groupId': 'OG000'}]}]}, {'title': 'Topiramate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.191', 'spread': '0.122', 'groupId': 'OG000'}]}]}, {'title': 'Qsymia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.228', 'spread': '0.122', 'groupId': 'OG000'}]}]}, {'title': 'Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.185', 'spread': '0.140', 'groupId': 'OG000'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.215', 'spread': '0.109', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohorts 2: Six one-day overnight inpatient stays over a six to twelve week period.', 'description': "Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold.", 'unitOfMeasure': 'kcal/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'missed visits due to Covid etc.'}, {'type': 'PRIMARY', 'title': 'Resting Energy Expenditure at Low Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)'}], 'classes': [{'title': 'Placebo for Mirabegron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Mirabegron 50mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Mirabegron 200mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 3: Four one-day overnight inpatient stays over a 12-week period.', 'description': "Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold.", 'unitOfMeasure': 'kcal/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'missed visits due to Covid etc.'}, {'type': 'PRIMARY', 'title': 'Basal Metabolic Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Chamber temperature will be block randomized with 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)'}], 'classes': [{'title': 'Placebo Cohort 1', 'categories': [{'measurements': [{'value': '1.153', 'spread': '0.098', 'groupId': 'OG000'}]}]}, {'title': 'Propranolol', 'categories': [{'measurements': [{'value': '1.053', 'spread': '0.099', 'groupId': 'OG000'}]}]}, {'title': 'Dantrolene', 'categories': [{'measurements': [{'value': '1.143', 'spread': '0.105', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium sulfate', 'categories': [{'measurements': [{'value': '1.108', 'spread': '0.124', 'groupId': 'OG000'}]}]}, {'title': 'Pindolol', 'categories': [{'measurements': [{'value': '1.116', 'spread': '0.109', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 1: Days 1-17', 'description': 'Basal metabolic rate (BMR) is the resting energy expenditure (REE) at thermoneutrality (27c).', 'unitOfMeasure': 'kcal/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cohort 1'}, {'type': 'PRIMARY', 'title': 'Brown Adipose Tissue Activity (Cohort 3 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)'}], 'classes': [{'title': 'Placebo for Mirabegron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Mirabegron 50 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '215.3', 'spread': '446.2', 'groupId': 'OG000'}]}]}, {'title': 'Mirabegron 200mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '554.3', 'spread': '903.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cohort 3: Four one-day overnight inpatient stays over a 12-week period.', 'description': 'Brown adipose tissue (BAT) activity is a quantification of tissue volume and metabolic activity per unit volume.', 'unitOfMeasure': 'mL*SUVmean*g/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'missed visits due to Covid etc.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'Chamber temperature will be block randomized with low temperature and 27°C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)'}, {'id': 'FG002', 'title': 'Cohort 3', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Chamber temperature will be block randomized with low temperature and 27C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)'}, {'id': 'BG002', 'title': 'Cohort 3', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '4', 'groupId': 'BG001'}, {'value': '25.1', 'spread': '4.6', 'groupId': 'BG002'}, {'value': '26.5', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-22', 'size': 797747, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-22T13:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06-11', 'completionDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2013-09-21', 'resultsFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2013-09-21', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-24', 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Energy Expenditure at Low Temperature', 'timeFrame': 'Cohort 1: Days 1-17', 'description': "Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold."}, {'measure': 'Resting Energy Expenditure at Low Temperature', 'timeFrame': 'Cohorts 2: Six one-day overnight inpatient stays over a six to twelve week period.', 'description': "Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold."}, {'measure': 'Resting Energy Expenditure at Low Temperature', 'timeFrame': 'Cohort 3: Four one-day overnight inpatient stays over a 12-week period.', 'description': "Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold."}, {'measure': 'Basal Metabolic Rate', 'timeFrame': 'Cohort 1: Days 1-17', 'description': 'Basal metabolic rate (BMR) is the resting energy expenditure (REE) at thermoneutrality (27c).'}, {'measure': 'Brown Adipose Tissue Activity (Cohort 3 Only)', 'timeFrame': 'Cohort 3: Four one-day overnight inpatient stays over a 12-week period.', 'description': 'Brown adipose tissue (BAT) activity is a quantification of tissue volume and metabolic activity per unit volume.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adipose Tissue', 'Adult', 'Resting Energy Expenditure', 'RESPIRATORY QUOTIENT', 'BASAL METABOLIC RATE'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '21177944', 'type': 'BACKGROUND', 'citation': 'Cannon B, Nedergaard J. Nonshivering thermogenesis and its adequate measurement in metabolic studies. J Exp Biol. 2011 Jan 15;214(Pt 2):242-53. doi: 10.1242/jeb.050989.'}, {'pmid': '21490370', 'type': 'BACKGROUND', 'citation': 'van Marken Lichtenbelt WD, Schrauwen P. Implications of nonshivering thermogenesis for energy balance regulation in humans. Am J Physiol Regul Integr Comp Physiol. 2011 Aug;301(2):R285-96. doi: 10.1152/ajpregu.00652.2010. Epub 2011 Apr 13.'}, {'pmid': '17473055', 'type': 'BACKGROUND', 'citation': 'Nedergaard J, Bengtsson T, Cannon B. Unexpected evidence for active brown adipose tissue in adult humans. Am J Physiol Endocrinol Metab. 2007 Aug;293(2):E444-52. doi: 10.1152/ajpendo.00691.2006. Epub 2007 May 1.'}, {'pmid': '29980535', 'type': 'DERIVED', 'citation': "Baskin AS, Linderman JD, Brychta RJ, McGehee S, Anflick-Chames E, Cero C, Johnson JW, O'Mara AE, Fletcher LA, Leitner BP, Duckworth CJ, Huang S, Cai H, Garraffo HM, Millo CM, Dieckmann W, Tolstikov V, Chen EY, Gao F, Narain NR, Kiebish MA, Walter PJ, Herscovitch P, Chen KY, Cypess AM. Regulation of Human Adipose Tissue Activation, Gallbladder Size, and Bile Acid Metabolism by a beta3-Adrenergic Receptor Agonist. Diabetes. 2018 Oct;67(10):2113-2125. doi: 10.2337/db18-0462. Epub 2018 Jul 6."}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2013-DK-0200.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': "Background:\n\n\\- Changes in how a person's body burns energy or calories can affect their weight over time. The lowest level of energy the body needs to function is called basal metabolic rate. In the cold, we burn extra energy, even before we start to shiver. This is called non-shivering thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers want to learn more about this type of energy burning and how it is regulated. They hope this will help treat obesity in the future.\n\nObjectives:\n\n* Sub-study 1: to better understand how non-shivering thermogenesis works.\n* Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate.\n* Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic receptor agonist, on brown fat activity.\n\nEligibility:\n\n\\- Healthy, lean adult males ages 18 to 35.\n\nDesign:\n\n* Participants will be screened with medical history, physical exam, blood test, and EKG.\n* For sub-studies 1 and 2:\n\n * Participants will receive one X-ray scan.\n * Each day, all participants will:\n* Have height and weight measured, and have urine collected.\n* Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering.\n* Walk for 30 minutes.\n* For sub-study 3:\n\n * Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs\n * Each stay, all participants will:\n* Have height and weight measured, and have urine collected.\n* Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering.\n* Participants will be compensated for their time and participation at the end of the study", 'detailedDescription': 'The balance between energy expenditure (EE) and energy intake ultimately determines body weight. Resting EE is the major component (60-75%) of total EE in an adult human being. Resting EE dynamically adapts to environmental changes such as ambient temperature. In our on-going study of environmental temperature changes within and around the thermoneutral zone, we observed that healthy young men can increase EE by 17 % of the basal metabolic rate through the process of non-shivering thermogenesis (NST). This capacity for NST is unexpectedly large as compared to prior reports of mild cold-induced thermogenesis (3 to 11%) and suggests that increasing NST could be explored as an intervention to combat obesity.\n\nThe aim of this study is to better understand the physiology of NST and to develop improved assays for evaluating the effect of drugs that alter EE. For example, only recently has it been realized that brown adipose tissue (BAT) is functional in adult humans and that white adipose tissue can be converted to brown-adipose-like tissue to increase heat production during cold exposures. Moreover, skeletal muscle likely also plays a role in cold-induced thermogenesis even before overt shivering occurs. It is plausible that the mechanisms governing heat production for NST contribute to regulation of body weight and thus may be contributing to the current obesity epidemic: even small changes in EE, if not compensated by changes in food intake, can have long-term effects on body weight.\n\nThis protocol has two phases. The first uses a pharmacologic approach to investigate the mechanism of NST in young healthy lean males. Since the principal physiologic stimulus to BAT (and possibly muscle for NST) is via the sympathetic nervous system (SNS), beta-adrenergic receptors may hold key roles in regulating human EE. We hypothesize that, by careful measurements of NST (at an individually-titrated cool environmental temperature, between 18 21 degrees C vs. at thermoneutrality of 27 degrees C) and using beta-adrenergic drugs that differ in receptor specificity and agonist/antagonist properties, we will gain better understanding of the regulation of human NST.\n\nThe second phase of the study focuses on measuring of FDA-approved drugs (such as anti-obesity drugs) potential effect on basal metabolic rate (BMR) under thermoneutral conditions. The rationale is that previous studies of drug effect on EE in humans have not always rigorously enforced the use of thermoneutral conditions, thus may have increased variability and underestimated the effect, contributing to inconclusive findings.\n\nIt is envisioned that this study will further our knowledge of the mechanisms that regulate the acute adaptive changes in resting energy expenditure and the effects of drug therapy targeting obesity in humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Generally healthy\n* Males between the age 18-35 years\n* Written informed consent.\n\nEXCLUSION CRITERIA:\n\n* BMI less than 18.5 or greater than 25.0 kg/M(2)\n* History of cardiovascular disease such as congestive heart failure, heart block, clinically abnormal EKG as determined by investigators\n* History of liver disease or ALT serum level greater than two times the laboratory upper limit of normal\n* History of kidney diseases or renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (MDRD equation)\n* History of cancer or bariatric surgery\n* History of diabetes mellitus or fasting serum glucose \\> 126 mg/dL\n* History of hypo- or hyper-thyroid or abnormal TSH, except minor deviations deemed to be of no clinical significance by the investigator.\n* History of asthma, chronic obstructive pulmonary disease and glaucoma\n* Psychological conditions, such as (but not limited to) claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study\n* Weight change \\>5 percent in the past 6 months or a trained athlete\n* Blood pressure greater than 140/90 mmHg or current antihypertensive therapy\n* Iron deficiency (Hemoglobin \\<13.7 g/dL and Hematocrit \\<40.1%)\n* History of illicit drug, opioids, or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE greater than or equal to 2) (95)\n* Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism\n* Current medications that may have interactions with study drugs as determined by the investigators\n* History of adverse or allergic reactions to the study drugs\n* Daily caffeine intake \\>500 mg (about 4 cups) and have withdrawal symptoms\n* Current smoker or user of tobacco products\n* Cannot commit to the schedule of visits to the Clinical Research Center (CRC) as required by the study timeline\n* Have had previous radiation exposure within the last year (X-rays, PET scans, etc.) that would exceed research limits (please let us know if you have received radiation for research purposes)\n* Have inflexible dietary restrictions\n* Any other reason that the investigator thinks would make interpretation of the study results difficult.\n* For subjects having an MRD (cOHORT 3), history of pacemaker, metallic heart valves, aneurysm clip, pedicle screws, metallic foreign body in eye, or other metallic implant.\n* For subjects receiving mirabegron (Cohort 3), a diagnosis of bladder outlet obstruction or the use of antimuscarinic medications for the treatment of overactive bladder.'}, 'identificationModule': {'nctId': 'NCT01950520', 'briefTitle': 'Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate', 'orgStudyIdInfo': {'id': '130200'}, 'secondaryIdInfos': [{'id': '13-DK-0200'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Chamber temperature will be block randomized with low temperature and 27°C (Cohort 1 only)\n\nWithin each block, the following five interventions will be repeated:\n\nPropranolol: Propanolol 160mg, oral, by mouth (Cohort 1 only)\n\nPindolol: Pindolol 20mg, oral, by mouth (Cohort 1 only)\n\nDantrolene: Dantrolene 100mg, oral, by mouth (Cohort 1 only)\n\nMagnesium Sulfate: Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)\n\nPlacebo Cohort 1: Placebo, oral, by mouth (Cohort 1 only)', 'interventionNames': ['Drug: Propranolol', 'Drug: Pindolol', 'Drug: Dantrolene', 'Drug: Magnesium Sulfate', 'Drug: Placebo Cohort 1']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Interventions, in random order, will be administered during one of the six one-day stays\n\nCaffeine: Caffeine 200mg, oral, by mouth (Cohort 2 only)\n\nQsymia: Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)\n\nTopiramate: Topiramate 200mg, oral, by mouth (Cohort 2 only)\n\nPhentermine: Phentermine 37.5mg, oral, by mouth (Cohort 2 only)\n\nNaltrexone: Naltrexone 100mg, oral, by mouth (Cohort 2 only)\n\nPlacebo Cohort 2: Placebo, oral, by mouth (Cohort 2 only)', 'interventionNames': ['Drug: Caffeine', 'Drug: Qsymia', 'Drug: Topiramate', 'Behavioral: Phentermine', 'Drug: Naltrexone', 'Drug: Placebo Cohort 2']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Interventions, in random order, will be administered during one of the four overnight inpatient stays\n\nMirabegron 50mg: Mirabegron 50mg, oral, by mouth (Cohort 3 only)\n\nMirabegron 200mg: Mirabegron 200mg, oral, by mouth (Cohort 3 only)\n\nPlacebo for Mirabegron: Placebo for Mirabegron, oral, by mouth (Cohort 3 only)', 'interventionNames': ['Drug: Mirabegron 50mg', 'Drug: Mirabegron 200mg', 'Drug: Placebo for Mirabegron']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': 'Propanolol 160mg, oral, by mouth (Cohort 1 only)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Pindolol', 'type': 'DRUG', 'description': 'Pindolol 20mg, oral, by mouth (Cohort 1 only)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Dantrolene', 'type': 'DRUG', 'description': 'Dantrolene 100mg, oral, by mouth (Cohort 1 only)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Magnesium Sulfate', 'type': 'DRUG', 'description': 'Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'Caffeine 200mg, oral, by mouth (Cohort 2 only)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Qsymia', 'type': 'DRUG', 'description': 'Qsymia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Topiramate', 'type': 'DRUG', 'description': 'Topiramate 200mg, oral, by mouth (Cohort 2 only)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Phentermine', 'type': 'BEHAVIORAL', 'description': 'Phentermine 37.5mg, oral, by mouth (Cohort 2 only)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Naltrexone', 'type': 'DRUG', 'description': 'Naltrexone 100mg, oral, by mouth (Cohort 2 only)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Mirabegron 50mg', 'type': 'DRUG', 'description': 'Mirabegron 50mg, oral, by mouth (Cohort 3 only)', 'armGroupLabels': ['Cohort 3']}, {'name': 'Mirabegron 200mg', 'type': 'DRUG', 'description': 'Mirabegron 200mg, oral, by mouth (Cohort 3 only)', 'armGroupLabels': ['Cohort 3']}, {'name': 'Placebo Cohort 1', 'type': 'DRUG', 'description': 'Placebo, oral, by mouth (Cohort 1 only)', 'armGroupLabels': ['Cohort 1']}, {'name': 'Placebo Cohort 2', 'type': 'DRUG', 'description': 'Placebo, oral, by mouth (Cohort 2 only)', 'armGroupLabels': ['Cohort 2']}, {'name': 'Placebo for Mirabegron', 'type': 'DRUG', 'description': 'Placebo for Mirabegron, oral, by mouth (Cohort 3 only)', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Kong Y Chen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'IPD will be available by request to the PI following publication of results', 'ipdSharing': 'YES', 'description': '.All IPD that underlie results in a publication', 'accessCriteria': 'By request to PI with approved protocol to analyze IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}