Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT01786551
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2013-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'gadler@partners.org', 'phone': '617-732-5661', 'title': 'Gail K Adler', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': "An adverse event (AE) is any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease, whether or not associated with the subject's participation in the research. Unexpected and related/possibly research-related AEs were to be reported to the institutional review board (IRB). Expected AEs (documented in the protocol), were not reported to the IRB.", 'eventGroups': [{'id': 'EG000', 'title': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days'}], 'classes': [{'title': 'Pre-eplerenone, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.70', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Pre-eplerenone, 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.51', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Pre-eplerenone, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.47', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.75', 'spread': '0.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment', 'description': 'At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported for evaluable participants only. All participants who completed the study and had glucose data available.'}, {'type': 'SECONDARY', 'title': 'Post-prandial Glucose Serum Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days'}], 'classes': [{'title': 'Pre-eplerenone, baseline', 'categories': [{'measurements': [{'value': '91', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Pre-eplerenone, 2 hours', 'categories': [{'measurements': [{'value': '105', 'spread': '28', 'groupId': 'OG000'}]}]}, {'title': 'Pre-eplerenone, 4 hours', 'categories': [{'measurements': [{'value': '93', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, baseline', 'categories': [{'measurements': [{'value': '89', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, 2 hours', 'categories': [{'measurements': [{'value': '102', 'spread': '21', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, 4 hours', 'categories': [{'measurements': [{'value': '92', 'spread': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment', 'description': 'At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported for evaluable participants only. All participants who completed the study and had glucose data available.'}, {'type': 'SECONDARY', 'title': 'Post-prandial Insulin Serum Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days'}], 'classes': [{'title': 'Pre-eplerenone, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Pre-eplerenone, 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.0', 'spread': '45.7', 'groupId': 'OG000'}]}]}, {'title': 'Pre-eplerenone, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'Post-eplerenone, 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '6.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment', 'description': 'At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.', 'unitOfMeasure': 'uU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported for evaluable participants only. All participants who completed the study and had glucose data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline analysis population included all participants who completed the study and had glucose data available.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2013-02-04', 'resultsFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-11', 'studyFirstPostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels', 'timeFrame': 'Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment', 'description': 'At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.'}], 'secondaryOutcomes': [{'measure': 'Post-prandial Glucose Serum Levels', 'timeFrame': 'Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment', 'description': 'At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.'}, {'measure': 'Post-prandial Insulin Serum Levels', 'timeFrame': 'Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment', 'description': 'At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Systemic Proinflammatory State']}, 'referencesModule': {'references': [{'pmid': '23006216', 'type': 'RESULT', 'citation': 'Krug AW, Stelzner L, Rao AD, Lichtman AH, Williams GH, Adler GK. Effect of low dose mineralocorticoid receptor antagonist eplerenone on glucose and lipid metabolism in healthy adult males. Metabolism. 2013 Mar;62(3):386-91. doi: 10.1016/j.metabol.2012.08.011. Epub 2012 Sep 21.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy participants in a systemic proinflammatory state after a meal high in fat and glucose, which is associated with the pathogenesis of atherosclerosis.\n\nParticipants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m\\^2) between the ages of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks, participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to the first intervention (day1), the participant's usual diet (ad lib) will be supplemented with 2 bullion broths each day. Standardization of sodium intake is necessary as variations in dietary sodium intake may affect outcome measures. We will evaluate the following parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* 18-45 years\n* BMI between 20-25 kg/m\\^2\n\nExclusion Criteria:\n\n* evidence of cardiovascular, hepatic, renal \\[estimated glomerular filtration rate (GFR) \\<60 millimeter/minute (ml/min)\\] or any other organ system disease\n* Blood pressure equal to or less than 90/60 mmHg\n* prescription or herbal medications\n* smoking\n* alcohol consumption of more than 2 drinks per day\n* dietary supplements'}, 'identificationModule': {'nctId': 'NCT01786551', 'briefTitle': 'Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults', 'orgStudyIdInfo': {'id': '2010P002191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplerenone', 'description': 'Eplerenone 50 mg daily for 14 days', 'interventionNames': ['Drug: Eplerenone']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'description': '50 mg daily for 14 days', 'armGroupLabels': ['Eplerenone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gail K Adler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gail Kurr Adler', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}