Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT03098433
Status:
COMPLETED
Last Update Posted:
2021-03-26
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D014284', 'term': 'Triiodothyronine'}, {'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'francesco.celi@vcuhealth.org', 'phone': '804-828-9696', 'title': 'Francesco S. Celi, MD, MHSc.', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '20 months', 'eventGroups': [{'id': 'EG000', 'title': 'Three Treatments in Random Order', 'description': 'Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.\n\nInformation on the order of treatments was not collected.\n\nParticipants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.\n\nAt the second study visit one of the remaining two treatments will be randomly selected and administered.\n\nAt the third study visit the final treatment will be administered.\n\nThe order of administration will not be tracked.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Three Treatments in Random Order', 'description': 'Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order\n\nInformation on the order of treatments was not collected.\n\nParticipants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.\n\nAt the second study visit one of the remaining two treatments will be randomly selected and administered.\n\nAt the third study visit the final treatment will be administered.\n\nThe order of administration will not be tracked.'}], 'classes': [{'title': 'Liothyronine', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '8.8', 'groupId': 'OG000'}]}]}, {'title': 'Levothyroxine', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '6.5', 'groupId': 'OG000'}]}]}, {'title': 'Placebo', 'categories': [{'measurements': [{'value': '1', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'five hours', 'description': 'Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration', 'unitOfMeasure': 'millilitres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'I participant did not undergo echocardiogram'}, {'type': 'SECONDARY', 'title': 'Energy Expenditure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Three Treatments in Random Order', 'description': 'Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.\n\nInformation on the order of treatments was not collected.\n\nParticipants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.\n\nAt the second study visit one of the remaining two treatments will be randomly selected and administered.\n\nAt the third study visit the final treatment will be administered.\n\nThe order of administration will not be tracked.'}], 'classes': [{'title': 'Liothyronine', 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.067', 'groupId': 'OG000'}]}]}, {'title': 'Levothyroxine', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.058', 'groupId': 'OG000'}]}]}, {'title': 'Placebo', 'categories': [{'measurements': [{'value': '-0.007', 'spread': '0.062', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'five hours', 'description': 'Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Three Treatments in Random Order', 'description': 'Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.\n\nInformation on the order of treatments was not collected.\n\nParticipants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.\n\nAt the second study visit one of the remaining two treatments will be randomly selected and administered.\n\nAt the third study visit the final treatment will be administered.\n\nThe order of administration will not be analyzed therefore all participants are part of a single arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Three Treatments in Random Order', 'description': 'Each participant will receive a single dose of lithyronine, a single dose of levothyroxine, and a single dose of placebo, in a random order.\n\nInformation on the order of treatments was not collected.\n\nParticipants will attend three study visits. At the first study visit one of the three treatments will be randomly selected and administered.\n\nAt the second study visit one of the remaining two treatments will be randomly selected and administered.\n\nAt the third study visit the final treatment will be administered.\n\nThe order of administration will not be tracked.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '5.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-25', 'size': 253761, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-04-23T09:42', 'hasProtocol': False}, {'date': '2017-01-19', 'size': 275306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-02T17:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'double blind, crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2020-07-07', 'completionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2017-03-07', 'dispFirstSubmitQcDate': '2021-03-02', 'resultsFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2017-03-27', 'dispFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-02', 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output', 'timeFrame': 'five hours', 'description': 'Cardiac output measured by Echocaridogram, Difference in Stroke Volume Pre- and Post- Drug Administration'}], 'secondaryOutcomes': [{'measure': 'Energy Expenditure', 'timeFrame': 'five hours', 'description': 'Energy expenditure measured by Whole-Room Indirect Calorimeter, Difference in energy Expenditure Pre- and Post- Drug Administration Kcal'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35295986', 'type': 'DERIVED', 'citation': "Chen S, Wohlford GF, Vecchie' A, Carbone S, Yavuz S, Van Tassell B, Abbate A, Celi FS. Acute Effects of Liothyronine Administration on Cardiovascular System and Energy Metabolism in Healthy Volunteers. Front Endocrinol (Lausanne). 2022 Feb 28;13:843539. doi: 10.3389/fendo.2022.843539. eCollection 2022."}]}, 'descriptionModule': {'briefSummary': 'This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>20\\<30 kg/m2\n* TSH \\>0.5\\<5.0 mcIU/mL\n* Negative TPO antibodies\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of prescription drugs\n* Diabetes mellitus\n* Coronary artery disease\n* Hypertension\n* Anemia\n* Renal insufficiency\n* Liver disease or ALT \\>2.5 x the upper laboratory reference limit'}, 'identificationModule': {'nctId': 'NCT03098433', 'briefTitle': 'Effects of Liothyronine on Energy Expenditure and Cardiovascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Effects of Liothyronine on Energy Expenditure and Cardiovascular Function', 'orgStudyIdInfo': {'id': 'HM20005777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liothyronine', 'description': 'Each participant will receive a single dose of lithyronine', 'interventionNames': ['Drug: Liothyronine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levothyroxine', 'description': 'Each participant will receive a single dose of levothyroxine', 'interventionNames': ['Drug: Levothyroxine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Each participant will receive a single dose of placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Liothyronine', 'type': 'DRUG', 'description': 'Single dose', 'armGroupLabels': ['Liothyronine']}, {'name': 'Levothyroxine', 'type': 'DRUG', 'description': 'Active comparator', 'armGroupLabels': ['Levothyroxine']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Francesco S Celi, MD, MHSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}