Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-27 @ 8:47 AM
Study NCT ID:
NCT01950260
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Levothyroxine Post Radioactive Iodine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}], 'ancestors': [{'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': 'stan.marius@mayo.edu', 'phone': '507-284-2463', 'title': 'Dr. Marius N. Stan', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for each subject from enrollment until study completion, approximately 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.\n\nLevothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.\n\nPlacebo: Placebo to start at 4 weeks after RAI', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Overt Hypothyroidism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.\n\nLevothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.\n\nPlacebo: Placebo to start at 4 weeks after RAI'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Incidence of overt hypothyroidism at 8 weeks post radioactive iodine treatment (RAI). Overt hypothyroidism was defined as thyroid stimulating hormone (TSH) test result \\> 3.0 milliunits per liter (mIU/L) or thyroid hormone free T4 (fT4) \\< 0.8 nanograms per deciliter (ng/dL). Free T4 is the portion of total T4 thyroid hormone that is available to your tissues in your bloodstream.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hypothyroid-Health Related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.\n\nLevothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.\n\nPlacebo: Placebo to start at 4 weeks after RAI'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '25.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks, 8 weeks', 'description': 'The mean change in Quality of life scores was measured by the Hypothyroid-Health Related Quality of Life (HRQL) questionnaire. This questionnaire consists of 27 questions specifying the severity of the discomfort or symptoms of hypothyroidism using a 5 point scale for each question with "not at all"=1 to "all the time"=5. Higher scores are associated with a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Thyroid Specific Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.\n\nLevothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.\n\nPlacebo: Placebo to start at 4 weeks after RAI'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks, 8 weeks', 'description': "The mean change in quality of life scores was measured by the Thyroid Specific Questionnaire (TSQ). This questionnaire consists of 12 questions ranked on a four-point scale for each question where 0 is 'better than usual' and 3 is 'much less than usual'. A higher score indicates higher levels of dissatisfaction and a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.\n\nLevothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.\n\nPlacebo: Placebo to start at 4 weeks after RAI'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.\n\nLevothyroxine: Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.\n\nPlacebo: Placebo to start at 4 weeks after RAI'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '47', 'spread': '15', 'groupId': 'BG000'}, {'value': '48', 'spread': '13', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.5', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '73.4', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '70.9', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Thyroid size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.7', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '31.4', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '32', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-12', 'size': 434320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-01T16:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2013-09-23', 'resultsFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-11', 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Overt Hypothyroidism', 'timeFrame': '8 weeks', 'description': 'Incidence of overt hypothyroidism at 8 weeks post radioactive iodine treatment (RAI). Overt hypothyroidism was defined as thyroid stimulating hormone (TSH) test result \\> 3.0 milliunits per liter (mIU/L) or thyroid hormone free T4 (fT4) \\< 0.8 nanograms per deciliter (ng/dL). Free T4 is the portion of total T4 thyroid hormone that is available to your tissues in your bloodstream.'}], 'secondaryOutcomes': [{'measure': 'Change in Hypothyroid-Health Related Quality of Life', 'timeFrame': '4 weeks, 8 weeks', 'description': 'The mean change in Quality of life scores was measured by the Hypothyroid-Health Related Quality of Life (HRQL) questionnaire. This questionnaire consists of 27 questions specifying the severity of the discomfort or symptoms of hypothyroidism using a 5 point scale for each question with "not at all"=1 to "all the time"=5. Higher scores are associated with a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point.'}, {'measure': 'Change in Thyroid Specific Quality of Life', 'timeFrame': '4 weeks, 8 weeks', 'description': "The mean change in quality of life scores was measured by the Thyroid Specific Questionnaire (TSQ). This questionnaire consists of 12 questions ranked on a four-point scale for each question where 0 is 'better than usual' and 3 is 'much less than usual'. A higher score indicates higher levels of dissatisfaction and a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Graves' disease", 'Radioactive iodine', 'Hypothyroidism'], 'conditions': ["Graves' Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low thyroid hormone levels)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n-all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD\n\nExclusion criteria:\n\n* clinically manifest Graves' ophthalmopathy (GO)\n* recent (\\<1 yr.) history of arrhythmias or any history of ventricular arrhythmias\n* preexistent cardiomyopathy\n* malnutrition\n* psychiatric history that could get worse if patient remains persistently hyperthyroid\n* unlikely to return for the planned follow-up visits\n* unlikely to comply with the blood drawing schedule\n* unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires"}, 'identificationModule': {'nctId': 'NCT01950260', 'briefTitle': 'Early Levothyroxine Post Radioactive Iodine', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease", 'orgStudyIdInfo': {'id': '13-002570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levothyroxine', 'description': 'In the intervention arm patients will start levothyroxine therapy at 4 weeks after RAI therapy. The initial dose of levothyroxine will be 25 mcg/day. It will be increased to 50 mcg/day 2 weeks later and then adjusted at 8 weeks post RAI based on a full face-to-face clinical and biochemical evaluation.', 'interventionNames': ['Drug: Levothyroxine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In the control arm patients will receive placebo capsules and be evaluated for levothyroxine therapy during a full face-to-face evaluation at 8 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Levothyroxine', 'type': 'DRUG', 'otherNames': ['Thyroid hormone'], 'description': 'Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).', 'armGroupLabels': ['Levothyroxine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo to start at 4 weeks after RAI', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Marius Stan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Endocrinology Consultant', 'investigatorFullName': 'Marius Stan', 'investigatorAffiliation': 'Mayo Clinic'}}}}