Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01409993
Status:
TERMINATED
Last Update Posted:
2017-04-17
First Post:
2011-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D015309', 'term': 'Glucose Clamp Technique'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nancy.j.brown@vanderbilt.edu', 'phone': '6153438701', 'title': 'Nancy J. Brown, M.D., Principal Investigator', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sildenafil - Aims 1 and 2', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.', 'otherNumAtRisk': 39, 'otherNumAffected': 32, 'seriousNumAtRisk': 39, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo - Aims 1 and 2', 'description': 'matching placebo p.o. tid\n\nAdministration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.', 'otherNumAtRisk': 39, 'otherNumAffected': 25, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadeness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Smell or taste abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abnormal uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'transient numbness', 'notes': 'numbness related to IV placement e.g.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hypertension and bradycardia', 'notes': 'Patient hospitalized with systolic blood pressure of 190 mm Hg and bradycardia. During hospitalization tested positive for a sympathomimetic drug. Subject was withdrawn from study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Secretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil Aim 1', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG001', 'title': 'Placebo Aim 1', 'description': 'matching placebo p.o. tid\n\nAdministration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '109.4', 'spread': '85', 'groupId': 'OG000'}, {'value': '103.1', 'spread': '67.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 hours after 3 months of therapy', 'description': 'in the group of subjects undergoing hyperglycemic clamp (Aim 1)', 'unitOfMeasure': 'microU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Glucose-stimulated insulin secretion from 90 to 120 minutes of hyperglycemic clamp'}, {'type': 'PRIMARY', 'title': 'Index of Tissue Sensitivity to Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil Aim 1', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG001', 'title': 'Placebo Aim 1', 'description': 'matching placebo p.o. tid\n\nAdministration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.45', 'spread': '0.661', 'groupId': 'OG000'}, {'value': '4.66', 'spread': '0.661', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 hours after 3 months of therapy', 'description': 'in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval', 'unitOfMeasure': '(mg/kg/min per microU/mL)*100', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Glucose Infusion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil Aim 2', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of Sildenafil : Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG001', 'title': 'Placebo Aim 2', 'description': 'matching placebo p.o. tid\n\nAdministration of Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '140.45', 'spread': '38.38', 'groupId': 'OG000'}, {'value': '162.61', 'spread': '64.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 hours after 3 months of therapy', 'description': 'In the group of subjects undergoing euglycemic clamp (Aim 2)', 'unitOfMeasure': 'mL/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'one subject in the sildenafil Aim 2 arm has incomplete data from the three-month clamp due to infusion dysfunction'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil Aim 1', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of Sildenafil : Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG001', 'title': 'Placebo Aim 1', 'description': 'matching placebo p.o. tid\n\nAdministration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG002', 'title': 'Sildenafil Aim 2', 'description': 'sildenafil 25 mg p.o. tid\n\nSildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG003', 'title': 'Placebo Aim 2', 'description': 'matching placebo p.o. tid\n\nPlacebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '96.9', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '98.8', 'spread': '6.5', 'groupId': 'OG002'}, {'value': '97.5', 'spread': '11.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sildenafil Aim 1', 'description': 'sildenafil 25 mg p.o. tid\n\nSildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG001', 'title': 'Placebo Aim 1', 'description': 'matching placebo p.o. tid\n\nPlacebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG002', 'title': 'Sildenafil Aim 2', 'description': 'sildenafil 25 mg p.o. tid\n\nSildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'OG003', 'title': 'Placebo Aim 2', 'description': 'matching placebo p.o. tid\n\nPlacebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '123.1', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '114.3', 'spread': '11.6', 'groupId': 'OG002'}, {'value': '112.5', 'spread': '22.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Systolic blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sildenafil Aim 1', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'FG001', 'title': 'Placebo Aim 1', 'description': 'matching placebo p.o. tid\n\nAdministration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'FG002', 'title': 'Sildenafil Aim 2', 'description': 'Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive sildenafil for 3 months. Another euglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'FG003', 'title': 'Placebo Aim 2', 'description': 'Administration of Placebo: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sildenafil', 'description': 'sildenafil 25 mg p.o. tid\n\nAdministration of sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'matching placebo p.o. tid\n\nAdministration of placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '49.58', 'spread': '10.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'whyStopped': 'Aim 1 was stopped by DSMB. Aim 2 was stopped due to ending of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2011-07-11', 'resultsFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Secretion', 'timeFrame': '2.5 hours after 3 months of therapy', 'description': 'in the group of subjects undergoing hyperglycemic clamp (Aim 1)'}, {'measure': 'Index of Tissue Sensitivity to Insulin', 'timeFrame': '2.5 hours after 3 months of therapy', 'description': 'in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval'}, {'measure': 'Glucose Infusion Rate', 'timeFrame': '2.5 hours after 3 months of therapy', 'description': 'In the group of subjects undergoing euglycemic clamp (Aim 2)'}], 'secondaryOutcomes': [{'measure': 'Fasting Plasma Glucose', 'timeFrame': '3 months'}, {'measure': 'Blood Pressure', 'timeFrame': '3 months', 'description': 'Systolic blood pressure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BMI greater than 25', 'Elevated fasting blood sugar (100-125mg/dL)'], 'conditions': ['Impaired Glucose Tolerance']}, 'referencesModule': {'references': [{'pmid': '26580240', 'type': 'BACKGROUND', 'citation': 'Ramirez CE, Nian H, Yu C, Gamboa JL, Luther JM, Brown NJ, Shibao CA. Treatment with Sildenafil Improves Insulin Sensitivity in Prediabetes: A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2015 Dec;100(12):4533-40. doi: 10.1210/jc.2015-3415. Epub 2015 Nov 18.'}, {'pmid': '25173047', 'type': 'DERIVED', 'citation': 'Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of chronic PDE5 inhibitor therapy on glucose metabolism in persons with prediabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nAge \\> 18 years and BMI \\> 25 kg/M2 (\\> 23 kg/M2 among Asian Americans) Elevated fasting plasma glucose (100-125 mg/dL) IGT (2 hour plasma glucose 140-199 mg/dL) OR metabolic syndrome and/or hemoglobin A1c 5.7-6.4%\n\nExclusion criteria:\n\n* Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater, a two hour plasma glucose of 200 mg/dL or greater, or the use of anti-diabetic medication.\n* The use of nitrates or any disease that might require the use of nitrates.\n* The use of any potent CYP3A4 inhibitor.\n* subjects who have participated in a weight-reduction program during the last 6 month or whose weight has increased or decreased more than 2 kg over the preceding 6 months.\n* Pregnancy. Women of child-bearing potential will be required to have undergone tubal ligation or to be using barrier methods of birth control.\n* Breast-feeding.\n* Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy.\n* Treatment with anticoagulants.\n* Treatment with metformin.\n* History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.\n* History or presence of immunological or hematological disorders.\n* Diagnosis of asthma.\n* Clinically significant gastrointestinal impairment that could interfere with drug absorption.\n* Impaired hepatic function (aspartate amino transaminase \\[AST\\] and/or alanine amino.\n\ntransaminase \\[ALT\\] \\>1.5 x upper limit of normal range)\n\n* Impaired renal function (serum creatinine \\>1.5 mg/dl).\n* Hematocrit \\<35%.\n* Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult.\n* Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in\n\n 1 month).\n* Treatment with lithium salts.\n* History of alcohol or drug abuse.\n* Treatment with any investigational drug in the 1 month preceding the study.\n* Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study.\n* Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study'}, 'identificationModule': {'nctId': 'NCT01409993', 'briefTitle': 'Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'orgStudyIdInfo': {'id': '110206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sildenafil Aim 1', 'description': 'sildenafil 25 mg p.o. tid', 'interventionNames': ['Drug: Sildenafil', 'Diagnostic Test: Hyperglycemic clamp']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo Aim 1', 'description': 'matching placebo p.o. tid', 'interventionNames': ['Drug: Placebo', 'Diagnostic Test: Hyperglycemic clamp']}, {'type': 'EXPERIMENTAL', 'label': 'sildenafil Aim 2', 'description': 'sildenafil 25 mg p.o. tid', 'interventionNames': ['Drug: Sildenafil', 'Diagnostic Test: Euglycemic clamp']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo Aim 2', 'description': 'matching placebo p.o. tid', 'interventionNames': ['Drug: Placebo', 'Diagnostic Test: Euglycemic clamp']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'description': 'Sildenafil 25 mg by mouth three times a day for three months', 'armGroupLabels': ['sildenafil Aim 1', 'sildenafil Aim 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo three times a day for three months', 'armGroupLabels': ['placebo Aim 1', 'placebo Aim 2']}, {'name': 'Hyperglycemic clamp', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.', 'armGroupLabels': ['placebo Aim 1', 'sildenafil Aim 1']}, {'name': 'Euglycemic clamp', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil or placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.', 'armGroupLabels': ['placebo Aim 2', 'sildenafil Aim 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Nancy J Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hugh J. Morgan Professor of Medicine and Pharmacology', 'investigatorFullName': 'Nancy J. Brown', 'investigatorAffiliation': 'Vanderbilt University'}}}}