Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02034435
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2014-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}, {'id': 'D012492', 'term': 'Salts'}, {'id': 'D000077545', 'term': 'Eplerenone'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.luther@vumc.org', 'phone': '(615) 936-3420', 'title': 'Dr. James M. Luther, MD', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Monitoring during 1 week of intervention/drug, washout period, and during cross-over to 1 week of remaining intervention/drug. Monitoring for adverse events continued up to 2 weeks after study completion.', 'eventGroups': [{'id': 'EG000', 'title': 'Aim 1- Low Sodium', 'description': 'Low Sodium diet (50mEq/d)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 7, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aim 1- High Sodium', 'description': 'Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 10, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aim 2- Eplerenone', 'description': 'Low sodium diet (50mEq/d) plus Eplerenone', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Aim 2- Amlodipine', 'description': 'Low sodium diet (50mEq/d) plus Amlodipine', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'notes': 'Headache during study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'viral illness', 'notes': 'Unrelated viral or other illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low glucose', 'notes': 'low glucose after clamp, resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'IV infiltration or malfunction', 'notes': 'bruising, swelling, or pain at IV site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'numbness', 'notes': 'temporary numbess in hand, resolved spontaneously', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'discomfort with swallowing pill', 'notes': 'temporary discomfort when swallowing tablets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'rectal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 1- Low Sodium', 'description': 'Low Sodium diet (50mEq/d)'}, {'id': 'OG001', 'title': 'Aim 1- High Sodium', 'description': 'Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)'}, {'id': 'OG002', 'title': 'Aim 2- Eplerenone', 'description': 'Low sodium diet (50mEq/d) plus Eplerenone'}, {'id': 'OG003', 'title': 'Aim 2- Amlodipine', 'description': 'Low sodium diet (50mEq/d) plus Amlodipine'}], 'classes': [{'categories': [{'measurements': [{'value': '293.1', 'groupId': 'OG000', 'lowerLimit': '186.9', 'upperLimit': '369.4'}, {'value': '234.7', 'groupId': 'OG001', 'lowerLimit': '161.3', 'upperLimit': '479.7'}, {'value': '330.8', 'groupId': 'OG002', 'lowerLimit': '268.2', 'upperLimit': '481.5'}, {'value': '300.4', 'groupId': 'OG003', 'lowerLimit': '177.8', 'upperLimit': '477.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'After 8 days of diet or drug', 'description': 'Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes', 'unitOfMeasure': 'uU/mL*10min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with metabolic syndrome'}, {'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aim 1- Low Sodium', 'description': 'Low Sodium diet (50mEq/d)'}, {'id': 'OG001', 'title': 'Aim 1- High Sodium', 'description': 'Low sodium diet (50mEq/d) plus sodium tablet (150 mEq/d)'}, {'id': 'OG002', 'title': 'Aim 2- Eplerenone', 'description': 'Low sodium diet (50mEq/d) plus Eplerenone'}, {'id': 'OG003', 'title': 'Aim 2- Amlodipine', 'description': 'Low sodium diet (50mEq/d) plus Amlodipine'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '7.6'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '7.6'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '8.2'}, {'value': '6.3', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '7.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after 8 days of diet or medication', 'description': 'Hyperinsulinemic clamp- glucose infusion rate during insulin administration', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with metabolic syndrome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aim1-Low Sodium Then High Sodium', 'description': 'Subjects will be provided with a low sodium diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.\n\nParticipants will be given low sodium diet (50mEq/d) and Placebo tablets for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Salt tables (150mEq) for 8days and assessments will be made.\n\nLow Salt diet plus Placebo tablet\n\nLow Sodium diet plus Salt tablet'}, {'id': 'FG001', 'title': 'Aim 1-High Sodium Then Low Sodium', 'description': 'Subjects will be provided with a diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.\n\nParticipants will be given low sodium diet (50mEq/d) and Salt tables (150mEq) for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Placebo tablets for 8days and assessments will be made.\n\nLow Salt diet plus Placebo tablet\n\nLow Sodium diet plus Salt tablet'}, {'id': 'FG002', 'title': 'Aim2- Low Sodium Diet and Epleronone Then Amlodipine', 'description': 'Subjects on a low salt diet will receive Epleronone 50mg for 8 days and assessments will be made, then cross over to a low salt diet with Amlodipine 5mg for 8days and assessments will be made.\n\nLow Salt diet plus Placebo tablet\n\nEpleronone: 50mg daily\n\nAmlodipine: 5mg daily'}, {'id': 'FG003', 'title': 'Aim2- Low Sodium Diet and Amlodipine Then Epleronone', 'description': 'Subjects on a low salt diet will receive Amlodipine 5mg for 8 days and assessments will be made, then cross over to a low salt diet with Epleronone 50mg for 8days and assessments will be made.\n\nLow Salt diet plus Placebo tablet\n\nEpleronone: 50mg daily\n\nAmlodipine: 5mg daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Aim 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Aim 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Inadequate IV access', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aim 1', 'description': 'Low Sodium and High Sodium diet crossover'}, {'id': 'BG001', 'title': 'Aim 2', 'description': 'Eplerenone and Amlodipine crossover'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '56'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '56'}, {'value': '45', 'groupId': 'BG002', 'lowerLimit': '40', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-04', 'size': 1189997, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-02T11:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2014-01-09', 'resultsFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-06', 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Secretion', 'timeFrame': 'After 8 days of diet or drug', 'description': 'Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes'}, {'measure': 'Insulin Sensitivity', 'timeFrame': 'after 8 days of diet or medication', 'description': 'Hyperinsulinemic clamp- glucose infusion rate during insulin administration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion.\n\nAim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.', 'detailedDescription': 'In aim 1 subjects are randomized to cross over between an 8 day high salt and 8 day low salt diet and assessments are made.\n\nIn aim 2, subjects are randomized to a 2x2 cross over study with an 8 day low salt diet and either eplerenone 50mg or amlodipine 5mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ambulatory subjects, 18 to 70 years of age, inclusive\n2. For female subjects, the following conditions must be met:\n\n 1. postmenopausal status for at least 1 year, or\n 2. status-post surgical sterilization, or\n 3. if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day.\n3. Metabolic Syndrome as defined by the presence of \\> 3 of the following:\n\n 1. Systolic Blood Pressure \\> 130 mm Hg OR Diastolic Blood Pressure \\> 85 mm Hg.\n 2. Glucose Intolerance (Fasting Plasma Glucose ≥ 100 mg/dL)\n 3. Increased triglyceride level \\> 150mg/dL (1.7mmol/L)\n 4. Decreased levels of HDL cholesterol (For males, less than 40 mg/dL; For females, less than 50 mg/dL)\n 5. Waist circumference (For males, greater than 40 inches; For females, greater than 35 inches)\n\nExclusion Criteria:\n\n1. type 1 Diabetes\n2. Type II Diabetes\n3. Impaired renal function\n4. Prior allergies to medications used in the study protocol\n5. Screening plasma potassium \\>5.5 mmol/L or sodium \\<135 mmol/L\n6. Cardiovascular disease\n7. Use of hormone replacement therapy\n8. Breast-feeding\n9. Treatment with anticoagulants\n10. History of serious neurologic disease\n11. History or presence of immunological or hematological disorders\n12. Diagnosis of asthma requiring use of inhaled beta agonist\n13. Clinically significant gastrointestinal impairment\n14. Impaired hepatic function\n15. Hematocrit \\<35%\n16. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs\n17. Treatment with chronic systemic glucocorticoid therapy\n18. Treatment with lithium salts\n19. History of alcohol or drug abuse\n20. Treatment with any investigational drug in the 1 month preceding\n21. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study\n22. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study'}, 'identificationModule': {'nctId': 'NCT02034435', 'briefTitle': 'Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism', 'orgStudyIdInfo': {'id': '131139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aim1-Low Sodium then High Sodium', 'description': 'Subjects will be provided with a low sodium diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.\n\nParticipants will be given low sodium diet (50mEq/d) and Placebo tablets for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Salt tables (150mEq) for 8days and assessments will be made.', 'interventionNames': ['Other: Low Salt diet plus Placebo tablet', 'Other: Low Sodium diet plus Salt tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aim 1-high salt diet then low salt diet', 'description': 'Subjects will be provided with a diet from the Vanderbilt Clinical Research Center that will be controlled for salt content.\n\nParticipants will be given low sodium diet (50mEq/d) and Salt tables (150mEq) for 8 days and assessments will be made, washout and then cross over to a low sodium diet (50mEq/d) plus Placebo tablets for 8days and assessments will be made.', 'interventionNames': ['Other: Low Salt diet plus Placebo tablet', 'Other: Low Sodium diet plus Salt tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aim2- low salt diet and epleronone then amlodipine', 'description': 'Subjects on a low salt diet will receive Epleronone 50mg for 8 days and assessments will be made, then cross over to a low salt diet with Amlodipine 5mg for 8days and assessments will be made.', 'interventionNames': ['Other: Low Salt diet plus Placebo tablet', 'Drug: Epleronone', 'Drug: Amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aim2- low salt diet and amlodipine then epleronone', 'description': 'Subjects on a low salt diet will receive Amlodipine 5mg for 8 days and assessments will be made, then cross over to a low salt diet with Epleronone 50mg for 8days and assessments will be made.', 'interventionNames': ['Other: Low Salt diet plus Placebo tablet', 'Drug: Epleronone', 'Drug: Amlodipine']}], 'interventions': [{'name': 'Low Salt diet plus Placebo tablet', 'type': 'OTHER', 'armGroupLabels': ['Aim 1-high salt diet then low salt diet', 'Aim1-Low Sodium then High Sodium', 'Aim2- low salt diet and epleronone then amlodipine', 'aim2- low salt diet and amlodipine then epleronone']}, {'name': 'Low Sodium diet plus Salt tablet', 'type': 'OTHER', 'armGroupLabels': ['Aim 1-high salt diet then low salt diet', 'Aim1-Low Sodium then High Sodium']}, {'name': 'Epleronone', 'type': 'DRUG', 'otherNames': ['Inspra'], 'description': '50mg daily', 'armGroupLabels': ['Aim2- low salt diet and epleronone then amlodipine', 'aim2- low salt diet and amlodipine then epleronone']}, {'name': 'Amlodipine', 'type': 'DRUG', 'otherNames': ['Norvasc'], 'description': '5mg daily', 'armGroupLabels': ['Aim2- low salt diet and epleronone then amlodipine', 'aim2- low salt diet and amlodipine then epleronone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-6602', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'James M Luther, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., MSCI', 'investigatorFullName': 'James Matt Luther', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}