Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT00732160
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aldosterone and Glucose Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'James.Luther@Vanderbilt.edu', 'phone': '(615) 936-3420', 'title': 'James M. Luther', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vehicle, HS', 'description': 'Vehicle Infusion, High Salt diet', 'otherNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle, LS', 'description': 'Vehicle Infusion, Low Salt diet', 'otherNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aldosterone, HS', 'description': 'Aldosterone Infusion, High Salt diet', 'otherNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Aldosterone, LS', 'description': 'Aldosterone Infusion, Low Salt diet', 'otherNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Low potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IV site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney stone', 'notes': 'during study diet, prior to drug infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion or rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle, HS', 'description': 'Vehicle Infusion, High Salt diet'}, {'id': 'OG001', 'title': 'Vehicle, LS', 'description': 'Vehicle Infusion, Low Salt diet'}, {'id': 'OG002', 'title': 'Aldosterone, HS', 'description': 'Aldosterone Infusion, High Salt diet'}, {'id': 'OG003', 'title': 'Aldosterone, LS', 'description': 'Aldosterone Infusion, Low Salt diet'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '34.8', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '30.9', 'groupId': 'OG001'}, {'value': '51.8', 'spread': '40.2', 'groupId': 'OG002'}, {'value': '34.4', 'spread': '20.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hours', 'description': 'Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)', 'unitOfMeasure': 'uU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle, HS', 'description': 'Vehicle Infusion, High Salt diet'}, {'id': 'OG001', 'title': 'Vehicle, LS', 'description': 'Vehicle Infusion, Low Salt diet'}, {'id': 'OG002', 'title': 'Aldosterone, HS', 'description': 'Aldosterone Infusion, High Salt diet'}, {'id': 'OG003', 'title': 'Aldosterone, LS', 'description': 'Aldosterone Infusion, Low Salt diet'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '17.3', 'groupId': 'OG002'}, {'value': '24.7', 'spread': '13.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hours', 'description': 'Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.', 'unitOfMeasure': 'mg/kg/min per uU/mL*100', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HS-V/A; LS-V/A', 'description': 'High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone'}, {'id': 'FG001', 'title': 'HS-A/V; LS-A/V', 'description': 'High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle'}, {'id': 'FG002', 'title': 'LS-V/A; HS-V/A', 'description': 'Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone'}, {'id': 'FG003', 'title': 'LS-A/V; HS-A/V', 'description': 'Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'HS Vehicle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'HS Aldosterone', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'LS Vehicle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'LS Aldosterone', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'scheduling', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '11 participants did not start the study (5 Participants did Not Meet inclusion or exclusion criteria, 6 declined participation)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'HS-V/A; LS-V/A', 'description': 'High Sodium diet- Vehicle then Aldosterone Low Sodium diet- Vehicle then Aldosterone'}, {'id': 'BG001', 'title': 'HS-A/V; LS-A/V', 'description': 'High Sodium diet- Aldosterone then Vehicle Low Sodium diet- Aldosterone then Vehicle'}, {'id': 'BG002', 'title': 'LS-V/A; HS-V/A', 'description': 'Low Sodium diet- Vehicle then Aldosterone High Sodium diet- Vehicle then Aldosterone'}, {'id': 'BG003', 'title': 'LS-A/V; HS-A/V', 'description': 'Low Sodium diet- Aldosterone then Vehicle High Sodium diet- Aldosterone then Vehicle'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'groupId': 'BG000', 'lowerLimit': '21.7', 'upperLimit': '30.1'}, {'value': '29.2', 'groupId': 'BG001', 'lowerLimit': '24.5', 'upperLimit': '36.5'}, {'value': '32.5', 'groupId': 'BG002', 'lowerLimit': '20.9', 'upperLimit': '47.5'}, {'value': '27.2', 'groupId': 'BG003', 'lowerLimit': '20.8', 'upperLimit': '30.8'}, {'value': '28.4', 'groupId': 'BG004', 'lowerLimit': '20.8', 'upperLimit': '47.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Glucose (mg/dL)', 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '85.4', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '85.3', 'spread': '7.6', 'groupId': 'BG002'}, {'value': '85.4', 'spread': '7.2', 'groupId': 'BG003'}, {'value': '85.3', 'spread': '7.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Healthy volunteers'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2008-08-05', 'resultsFirstSubmitDate': '2015-05-08', 'studyFirstSubmitQcDate': '2008-08-05', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-21', 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Secretion', 'timeFrame': '3 hours', 'description': 'Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)'}], 'secondaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': '3 hours', 'description': 'Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucose', 'Insulin'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25173047', 'type': 'DERIVED', 'citation': 'Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28.'}, {'pmid': '25029426', 'type': 'DERIVED', 'citation': 'Luther JM, Byrne LM, Yu C, Wang TJ, Brown NJ. Dietary sodium restriction decreases insulin secretion without affecting insulin sensitivity in humans. J Clin Endocrinol Metab. 2014 Oct;99(10):E1895-902. doi: 10.1210/jc.2014-2122. Epub 2014 Jul 16.'}, {'pmid': '24191286', 'type': 'DERIVED', 'citation': 'Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'Determine the effect of aldosterone on how the body handles glucose (sugar).', 'detailedDescription': 'Determine the effect of aldosterone on glucose metabolism in humans.'}, '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 a postmenopausal status for at least 1 year, or b status-post surgical sterilization, or c 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\na Systolic Blood Pressure \\> 130 mm Hg OR Diastolic Blood Pressure \\> 85 mm Hg. b Glucose Intolerance (Fasting Plasma Glucose \\> 100 mg/dL) c Increased triglyceride level \\> 150mg/dL (1.7mmol/L) d Decreased levels of HDL cholesterol For males, less than 40 mg/dL For females, less than 50 mg/dL e Waist circumference For males, greater than 40 inches (102 cm) For females, greater than 35 inches (89 cm).\n\nExclusion Criteria:\n\n1. Previously diagnosed Type I Diabetes , or the use of anti-diabetic medication. Subjects with type II diabetes not on medication will be allowed to participate if fasting blood glucose is \\<200mg/dL.\n2. Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride).\n3. Screening plasma potassium \\<3.5 mmol/L or use of chronic potassium supplements for the treatment of hypokalemia\n4. Use of hormone replacement therapy\n5. If on statin therapy for hypercholesterolemia, a change in dose within the past 6 months.\n6. Breast-feeding\n7. Cardiovascular disease such as prior myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy\n8. Treatment with anticoagulants\n9. History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack\n10. History or presence of immunological or hematological disorders\n11. Diagnosis of asthma requiring use of inhaled beta agonist \\>1 time per week\n12. Clinically significant gastrointestinal impairment that could interfere with drug absorption\n13. Impaired hepatic function \\[aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) \\>2.0 x upper limit of normal range\\]\n14. Impaired renal function \\[estimated glomerular filtration rate (eGFR) of \\<60ml/min\\] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years:\n15. eGFR \\<60 ml/min\n16. Hematocrit \\<35%\n17. 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\n18. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)\n19. Treatment with lithium salts\n20. History of alcohol or drug abuse\n21. Treatment with any investigational drug in the 1 month preceding the study\n22. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study\n23. 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': 'NCT00732160', 'briefTitle': 'Aldosterone and Glucose Homeostasis', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Aldosterone and Glucose Homeostasis', 'orgStudyIdInfo': {'id': '080248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-V/A; LS-V/A', 'description': 'High Sodium diet- Vehicle infusion then Aldosterone infusion Low Sodium diet- Vehicle infusion then Aldosterone infusion', 'interventionNames': ['Drug: Aldosterone infusion (A)', 'Drug: Vehicle Infusion (V)', 'Other: High Sodium Diet (HS)', 'Other: Low Sodium Diet (LS)']}, {'type': 'EXPERIMENTAL', 'label': 'HS-A/V; LS-A/V', 'description': 'High Sodium diet- Aldosterone infusion then Vehicle infusion Low Sodium diet- Aldosterone infusion then Vehicle infusion', 'interventionNames': ['Drug: Aldosterone infusion (A)', 'Drug: Vehicle Infusion (V)', 'Other: High Sodium Diet (HS)', 'Other: Low Sodium Diet (LS)']}, {'type': 'EXPERIMENTAL', 'label': 'LS-V/A; HS-V/A', 'description': 'Low Sodium diet- Vehicle infusion then Aldosterone infusion High Sodium diet- Vehicle infusion then Aldosterone infusion', 'interventionNames': ['Drug: Aldosterone infusion (A)', 'Drug: Vehicle Infusion (V)', 'Other: High Sodium Diet (HS)', 'Other: Low Sodium Diet (LS)']}, {'type': 'EXPERIMENTAL', 'label': 'LS-A/V; HS-A/V', 'description': 'Low Sodium diet- Aldosterone infusion then Vehicle infusion High Sodium diet- Aldosterone infusion then Vehicle infusion', 'interventionNames': ['Drug: Aldosterone infusion (A)', 'Drug: Vehicle Infusion (V)', 'Other: High Sodium Diet (HS)', 'Other: Low Sodium Diet (LS)']}], 'interventions': [{'name': 'Aldosterone infusion (A)', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Infusion of exogenous aldosterone (0.7 mcg/kg/hr for 12.5 hrs)', 'armGroupLabels': ['HS-A/V; LS-A/V', 'HS-V/A; LS-V/A', 'LS-A/V; HS-A/V', 'LS-V/A; HS-V/A']}, {'name': 'Vehicle Infusion (V)', 'type': 'DRUG', 'description': 'Vehicle infusion for 12.5 hours', 'armGroupLabels': ['HS-A/V; LS-A/V', 'HS-V/A; LS-V/A', 'LS-A/V; HS-A/V', 'LS-V/A; HS-V/A']}, {'name': 'High Sodium Diet (HS)', 'type': 'OTHER', 'description': '160 mmol/d sodium diet for 7 days', 'armGroupLabels': ['HS-A/V; LS-A/V', 'HS-V/A; LS-V/A', 'LS-A/V; HS-A/V', 'LS-V/A; HS-V/A']}, {'name': 'Low Sodium Diet (LS)', 'type': 'OTHER', 'description': '20 mmol/d sodium diet for 9 days', 'armGroupLabels': ['HS-A/V; LS-A/V', 'HS-V/A; LS-V/A', 'LS-A/V; HS-A/V', 'LS-V/A; HS-V/A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', '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', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'James Matt Luther', 'investigatorAffiliation': 'Vanderbilt University'}}}}