Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 6:08 AM
Study NCT ID:
NCT01444651
Status:
COMPLETED
Last Update Posted:
2017-01-30
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of Tadalafil and Glycemic Traits
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jho1@partners.org', 'phone': '617-726-6411', 'title': 'Dr. Jennifer Ho', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events recorded during study duration (3 months)', 'description': 'Adverse events ascertained at each follow-up visit', 'eventGroups': [{'id': 'EG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months', 'otherNumAtRisk': 36, 'otherNumAffected': 7, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months', 'otherNumAtRisk': 37, 'otherNumAffected': 2, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry vision and headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back or leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache and back ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arm pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.57', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '3.84', 'spread': '3.80', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3.81', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '3.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'groupDescription': 'Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = \\[fasting glucose \\* fasting insulin\\]/405', 'unitOfMeasure': 'mg*microunits/dL*mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.60', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '4.27', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '2.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'groupDescription': 'Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT \\[fasting glucose\\*fasting insulin\\* (mean glucose from time 30, 60, 90, 120 min) \\* (mean insulin at time 30, 60, 90, and 120 min)\\]', 'unitOfMeasure': 'unitless index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline to 3-month Change in Endothelial Function Measured by EndoPAT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)', 'unitOfMeasure': 'unitless index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulinogenic Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.39', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '2.06', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '2.62', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '2.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.77', 'groupDescription': 'Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = \\[fasting insulin - insulin at time 30 min\\] / \\[fasting glucose - glucose at time 30 min\\]', 'unitOfMeasure': 'unitless index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.74', 'spread': '11.56', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '3.67', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '4.48', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '5.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': 'Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin', 'unitOfMeasure': 'unitless index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline to 3-month Change in Matsuda Disposition Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.23', 'spread': '24.19', 'groupId': 'OG000'}, {'value': '6.67', 'spread': '9.45', 'groupId': 'OG001'}]}]}, {'title': '3-month', 'categories': [{'measurements': [{'value': '9.22', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '18.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'beta estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '8.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.05', 'groupDescription': 'Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = \\[Matsuda sensitivity index \\* insulinogenic index\\]', 'unitOfMeasure': 'unitless index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Non-fasting', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Missing data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '111 participants screened, 38 excluded (34 did not meet eligibility criteria, 2 unable to obtain intravenous access, 2 withdrew consent)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months\n\nTadalafil: 20 mg Tadalafil taken once a day for 3 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months\n\nPlacebo: Placebo tablet taken by mouth once a day for 3 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '9', 'groupId': 'BG000'}, {'value': '34', 'spread': '9', 'groupId': 'BG001'}, {'value': '33', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting insulin', 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '10', 'groupId': 'BG000'}, {'value': '17', 'spread': '16', 'groupId': 'BG001'}, {'value': '17', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microunits/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-04', 'studyFirstSubmitDate': '2011-08-03', 'resultsFirstSubmitDate': '2016-07-11', 'studyFirstSubmitQcDate': '2011-09-30', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-04', 'studyFirstPostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR', 'timeFrame': 'Baseline and 3 months', 'description': 'The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = \\[fasting glucose \\* fasting insulin\\]/405'}], 'secondaryOutcomes': [{'measure': 'Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index', 'timeFrame': 'Baseline and 3 months', 'description': 'The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT \\[fasting glucose\\*fasting insulin\\* (mean glucose from time 30, 60, 90, 120 min) \\* (mean insulin at time 30, 60, 90, and 120 min)\\]'}, {'measure': 'Baseline to 3-month Change in Endothelial Function Measured by EndoPAT', 'timeFrame': 'Baseline and 3 months', 'description': 'Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)'}, {'measure': 'Insulinogenic Index', 'timeFrame': 'Baseline and 3 months', 'description': 'The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = \\[fasting insulin - insulin at time 30 min\\] / \\[fasting glucose - glucose at time 30 min\\]'}, {'measure': 'Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index', 'timeFrame': 'Baseline and 3 months', 'description': 'The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin'}, {'measure': 'Baseline to 3-month Change in Matsuda Disposition Index', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = \\[Matsuda sensitivity index \\* insulinogenic index\\]'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tadalafil', 'Phosphodiesterase 5 Inhibitors', 'Cyclic Guanylyl Monophosphate Pathway', 'Pharmacologic Actions', 'Vasodilator Agents', 'Cardiovascular Agents', 'Obesity', 'Glycemic Traits', 'Insulin Resistance', 'Glucose Metabolism'], 'conditions': ['Cardiovascular Disease', 'Insulin Resistance', 'Glucose Intolerance', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '25213566', 'type': 'DERIVED', 'citation': 'Ho JE, Arora P, Walford GA, Ghorbani A, Guanaga DP, Dhakal BP, Nathan DI, Buys ES, Florez JC, Newton-Cheh C, Lewis GD, Wang TJ. Effect of phosphodiesterase inhibition on insulin resistance in obese individuals. J Am Heart Assoc. 2014 Sep 11;3(5):e001001. doi: 10.1161/JAHA.114.001001.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).', 'detailedDescription': 'This study is examining changes in insulin resistance and glucose tolerance following 3 months of treatment with oral, once daily tadalafil.\n\nThe investigators primary hypotheses are that measurable decreases in insulin resistance (as measured by HOMA-IR) and increases in insulin sensitivity (as measured by the Matsuda index) will occur following 3 months of treatment with oral tadalafil 20 mg daily compared to placebo.\n\nThe investigators secondary hypotheses are that improvements in average glycemia (as measured by hemoglobin A1C), pancreatic beta cell function (as measured by the oral disposition index), and body composition (including weight, waist circumference, body mass index, and waist-hip ratio) will occur as a result of tadalafil-mediated changes in the cGMP pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years and \\< 50 years\n* BMI \\> 30 kg/m2\n* Fasting insulin \\> 10 uU/mL\n\nExclusion Criteria:\n\n* Systolic blood pressure (SBP) \\< 100, \\> 150 mmHg\n* Current anti-hypertensive medication use, including diuretics\n* Current use of organic nitrates\n* Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)\n* History of reaction to PDE-5 inhibitors\n* Known HIV infection\n* Use of medications that strongly alter CYP3A4 activity\n* History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure\n* Known non-arteritic ischemic optic retinopathy (NAIOR)\n* History of hearing loss\n* Estimated glomerular filtration rate (eGFR) \\< 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation\n* Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal\n* Known pregnancy or those unwilling to avoid pregnancy during the course of the study\n* History of priapism\n* Use in excess of four alcoholic drinks daily\n* History of diabetes mellitus or use of anti-diabetic medications\n* Known anemia (men, Hct \\< 38% and women, Hct \\< 36%)'}, 'identificationModule': {'nctId': 'NCT01444651', 'briefTitle': 'A Trial of Tadalafil and Glycemic Traits', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase 3 Randomized Trial of Tadalafil and Glycemic Traits', 'orgStudyIdInfo': {'id': '2010P-001519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tadalafil', 'description': '20 mg Tadalafil tablet taken by mouth once a day for 3 months', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablet taken by mouth once a day for 3 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil', 'type': 'DRUG', 'otherNames': ['Adcirca, Cialis'], 'description': '20 mg Tadalafil taken once a day for 3 months', 'armGroupLabels': ['Tadalafil']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Placebo tablet taken by mouth once a day for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Thomas J Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas J. Wang, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, Harvard Medical School', 'investigatorFullName': 'Thomas J. Wang, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}