Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-05 @ 5:54 PM
Study NCT ID:
NCT01405456
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2011-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eplerenone in HIV Associated Abdominal Fat Accumulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D008060', 'term': 'Lipodystrophy'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgrinspoon@mgh.harvard.edu', 'phone': '6177249109', 'title': 'Dr. Steven K. Grinspoon', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Stimulated Glucose Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '7.70', 'groupId': 'OG000', 'lowerLimit': '5.01', 'upperLimit': '8.36'}, {'value': '8.58', 'groupId': 'OG001', 'lowerLimit': '5.76', 'upperLimit': '12.30'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/min per μIU/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visceral Adipose Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000', 'lowerLimit': '145', 'upperLimit': '327'}, {'value': '233', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '318'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Liver Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '13'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of intrahepatic lipid', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intramyocellular Lipid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.4'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of intramyocellular lipid', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Flow Mediated Vasodilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '17.3'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '20.4'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of maximum change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Mean serum measurements of Potassium', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '6.0'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '5.9'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Hemoglobin A1c from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '5.8'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '10.3'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in C-Reactive Protein from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasminogen Activator Inhibitor 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '3', 'groupId': 'OG000'}, {'value': '35', 'spread': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '4015', 'groupId': 'OG000', 'lowerLimit': '2926', 'upperLimit': '5588'}, {'value': '4014', 'groupId': 'OG001', 'lowerLimit': '3213', 'upperLimit': '6012'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Adiponectin from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Markers of Systemic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '16.6'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '27.8'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in IL-6 from baseline to 6 months', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'IL-6', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Markers of Immune Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'OG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'spread': '19', 'groupId': 'OG000'}, {'value': '210', 'spread': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in MCP-1 from baseline to 6 months', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'MCP-1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'FG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)\n\nEplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling'}, {'id': 'BG001', 'title': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification\n\nplacebo and lifestyle: placebo pill daily and lifestyle counseling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'spread': '6', 'groupId': 'BG000'}, {'value': '52', 'spread': '6', 'groupId': 'BG001'}, {'value': '51', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], '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': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin Stimulated Glucose Uptake', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.26', 'groupId': 'BG000', 'lowerLimit': '5.74', 'upperLimit': '9.55'}, {'value': '7.52', 'groupId': 'BG001', 'lowerLimit': '5.12', 'upperLimit': '10.43'}, {'value': '7.44', 'groupId': 'BG002', 'lowerLimit': '5.64', 'upperLimit': '9.87'}]}]}], 'paramType': 'MEDIAN', 'description': 'Insulin stimulated glucose uptake at steady state using the euglycemic hyperinsulinemic clamp technique normalized to insulin and lean body mass.', 'unitOfMeasure': 'mg/min per μIU/ml', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be obtained. Subject was unable to complete the procedure.'}, {'title': 'Visceral Adipose Tissue', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000', 'lowerLimit': '154', 'upperLimit': '324'}, {'value': '241', 'groupId': 'BG001', 'lowerLimit': '147', 'upperLimit': '295'}, {'value': '230', 'groupId': 'BG002', 'lowerLimit': '154', 'upperLimit': '308'}]}]}], 'paramType': 'MEDIAN', 'description': 'Abdominal visceral fat obtained by MRI.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be obtained. Subjects could could not complete the procedure.'}, {'title': 'Liver Fat', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'Intrahepatic lipid obtained by MRS.', 'unitOfMeasure': 'percentage of intrahepatic lipid', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be obtained. Subjects could not complete the procedure.'}, {'title': 'Intramyocellular Lipid', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'BG000', 'lowerLimit': '0.2', 'upperLimit': '0.6'}, {'value': '0.3', 'groupId': 'BG001', 'lowerLimit': '0.2', 'upperLimit': '0.5'}, {'value': '0.4', 'groupId': 'BG002', 'lowerLimit': '0.2', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEDIAN', 'description': 'Intramyocellular lipid of the tibialis anterior muscle obtained by MRS.', 'unitOfMeasure': 'percentage of intramyocellular lipid', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be obtained. Subjects could not complete the procedure.'}, {'title': 'Flow Mediated Vasodilation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'BG000', 'lowerLimit': '9.7', 'upperLimit': '19.3'}, {'value': '13.4', 'groupId': 'BG001', 'lowerLimit': '10.8', 'upperLimit': '17.6'}, {'value': '13.0', 'groupId': 'BG002', 'lowerLimit': '10.7', 'upperLimit': '17.6'}]}]}], 'paramType': 'MEDIAN', 'description': 'Flow mediated vasodilation obtained at the brachial artery.', 'unitOfMeasure': 'percentage of maximum change', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be obtained. Studies were of poor quality and data could not be analyzed.'}, {'title': 'Potassium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'BG000', 'lowerLimit': '5.5', 'upperLimit': '6.0'}, {'value': '5.8', 'groupId': 'BG001', 'lowerLimit': '5.3', 'upperLimit': '6.1'}, {'value': '5.7', 'groupId': 'BG002', 'lowerLimit': '5.5', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'C-reactive Protein', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'BG000', 'lowerLimit': '1.2', 'upperLimit': '9.4'}, {'value': '3.7', 'groupId': 'BG001', 'lowerLimit': '1.6', 'upperLimit': '9.8'}, {'value': '3.4', 'groupId': 'BG002', 'lowerLimit': '1.3', 'upperLimit': '9.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be evaluated. Sufficient sample was not obtained.'}, {'title': 'Plasminogen Activator Inhibitor 1', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.7', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '18.7', 'groupId': 'BG001'}, {'value': '36.9', 'spread': '18.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Endpoint could not be obtained. Sufficient sample was not obtained.'}, {'title': 'Adiponectin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4016', 'groupId': 'BG000', 'lowerLimit': '3439', 'upperLimit': '5360'}, {'value': '4673', 'groupId': 'BG001', 'lowerLimit': '3302', 'upperLimit': '6042'}, {'value': '4527', 'groupId': 'BG002', 'lowerLimit': '3373', 'upperLimit': '5484'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be evaluated. Sufficient sample was not obtained.'}, {'title': 'Markers of Systemic Inflammation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'BG000', 'lowerLimit': '5.2', 'upperLimit': '19.8'}, {'value': '7.9', 'groupId': 'BG001', 'lowerLimit': '6.1', 'upperLimit': '18.3'}, {'value': '9.1', 'groupId': 'BG002', 'lowerLimit': '5.9', 'upperLimit': '19.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'IL-6', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Endpoint could not be evaluated. Sufficient sample was not obtained.'}, {'title': 'Markers of Immune Activation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '205', 'spread': '78', 'groupId': 'BG000'}, {'value': '191', 'spread': '51', 'groupId': 'BG001'}, {'value': '198', 'spread': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'MCP-1', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Endpoint could not be evaluated. Sufficient sample was not obtained.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-01', 'size': 225779, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-16T10:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2011-07-27', 'resultsFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-16', 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Stimulated Glucose Uptake', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Visceral Adipose Tissue', 'timeFrame': '6 months'}, {'measure': 'Liver Fat', 'timeFrame': '6 months'}, {'measure': 'Intramyocellular Lipid', 'timeFrame': '6 months'}, {'measure': 'Flow Mediated Vasodilation', 'timeFrame': '6 months'}, {'measure': 'Potassium', 'timeFrame': '6 months'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '6 months'}, {'measure': 'C-Reactive Protein', 'timeFrame': '6 months'}, {'measure': 'Plasminogen Activator Inhibitor 1', 'timeFrame': '6 months'}, {'measure': 'Adiponectin', 'timeFrame': '6 months'}, {'measure': 'Markers of Systemic Inflammation', 'timeFrame': '6 months', 'description': 'IL-6'}, {'measure': 'Markers of Immune Activation', 'timeFrame': '6 months', 'description': 'MCP-1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV-infection', 'eplerenone', 'aldosterone', 'visceral fat', 'lipodystrophy'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '34909518', 'type': 'DERIVED', 'citation': 'Srinivasa S, deFilippi C, Fitch KV, Iyengar S, Shen G, Burdo TH, Walpert AR, Thomas TS, Adler GK, Grinspoon SK. Evaluation of Mineralocorticoid Receptor Antagonism on Changes in NT-proBNP Among Persons With HIV. J Endocr Soc. 2021 Nov 19;6(1):bvab175. doi: 10.1210/jendso/bvab175. eCollection 2022 Jan 1.'}, {'pmid': '29659888', 'type': 'DERIVED', 'citation': "Srinivasa S, Fitch KV, Wong K, O'Malley TK, Maehler P, Branch KL, Looby SE, Burdo TH, Martinez-Salazar EL, Torriani M, Lyons SH, Weiss J, Feldpausch M, Stanley TL, Adler GK, Grinspoon SK. Randomized, Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Metabolic and Inflammatory Indices in HIV. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2376-2384. doi: 10.1210/jc.2018-00330."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.', 'detailedDescription': 'The study is 12 months long, with two phases. In the initial, 6-month phase, volunteers are randomly assigned to receive either eplerenone or placebo (an inactive pill). In addition, all volunteers will receive counseling about healthy diet and lifestyle, and will be asked to follow guidelines for a healthy level of physical activity. In the second 6-months of the study, all volunteers will continue to receive lifestyle modification and all will receive eplerenone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Increased waist circumference based on NCEP guidelines (\\>102cm in men and \\>88cm in women) and impaired glucose tolerance (either IFG \\> 100 mg/dL but \\< 126 mg/dL or 2hr glucose \\> 140 mg/dl but \\< 200 mg/dL, or fasting insulin \\>12 uIU/mL)\n2. HIV positive for 5y and on a stable ART regimen for at least 12 months\n3. Age ≥ 30 and ≤ 65 years of age\n\nExclusion Criteria:\n\n1. ACE Inhibitor, ARB, verapamil, or spironolactone\n2. Potassium supplementation\n3. Estimated GFR\\<60, creatinine \\> 1.5 mg/dL\n4. Serum K \\> 5.5 mEq/L, ALT \\> 2.5 times the upper limit of normal, Hgb \\< 11g/dL\n5. Uncontrolled hypertension (SBP ≥ 160 or DBP ≥ 100)\n6. Current or prior steroid use within past 6 months\n7. Known history of diabetes mellitus or current use of anti-diabetic medications\n8. Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of CYP34A\n9. Use of St. John's Wart (CYP3A4 inducer)\n10. Pregnant or actively seeking pregnancy, breastfeeding\n11. For women: Pregnant or actively seeking pregnancy, breastfeeding, failure to use an acceptable non-hormonal form of birth control, including abstinence, barrier contraceptives, or non-hormonal IUD.\n12. Estrogen or progestational derivative use within 3 months\n13. Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for \\< 3 months.\n14. Current growth hormone or growth hormone releasing hormone use\n15. Current viral, bacterial or other infections (excluding HIV)\n16. Current active substance abuse\n17. Patients with a significant history of cardiovascular disease, including prior MI or stroke"}, 'identificationModule': {'nctId': 'NCT01405456', 'briefTitle': 'Eplerenone in HIV Associated Abdominal Fat Accumulation', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Randomized Placebo-controlled Trial to Investigate the Effects of Eplerenone in Patients With HIV-associated Abdominal Fat Accumulation', 'orgStudyIdInfo': {'id': '2010P002095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplerenone and Lifestyle', 'description': 'First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months)', 'interventionNames': ['Drug: Eplerenone and lifestyle']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Lifestyle', 'description': 'First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification', 'interventionNames': ['Other: placebo and lifestyle']}], 'interventions': [{'name': 'Eplerenone and lifestyle', 'type': 'DRUG', 'description': 'eplerenone 50mg by mouth daily as well as lifestyle counseling', 'armGroupLabels': ['Eplerenone and Lifestyle']}, {'name': 'placebo and lifestyle', 'type': 'OTHER', 'description': 'placebo pill daily and lifestyle counseling', 'armGroupLabels': ['Placebo and Lifestyle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Steven Grinspoon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steven K. Grinspoon, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}