Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT00330733
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2006-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014182', 'term': 'salicylsalicylic acid'}, {'id': 'D012980', 'term': 'Sodium Salicylate'}, {'id': 'C003185', 'term': 'polynoxylin'}], 'ancestors': [{'id': 'D020156', 'term': 'Salicylic Acid'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Peter.Reaven@va.gov', 'phone': '602 277 5551', 'title': 'Peter Reaven', 'phoneExt': '5817', 'organization': 'Phoenix VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Since we did not measure endogenous glucose production and lipolysis, the effects on hepatic glucose and lipid metabolism deserve further study. Sufficient numbers of women were not included, with which to confidently extend these results to women'}}, 'adverseEventsModule': {'timeFrame': '14 weeks (12 weeks active treatment + 2-week follow-up).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded \\> mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred.', 'otherNumAtRisk': 36, 'otherNumAffected': 7, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded \\> mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred.', 'otherNumAtRisk': 34, 'otherNumAffected': 12, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'tinnitus', 'notes': 'The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded \\> mild', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systemic Glucose Disposal- Glucose Infusion Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-39', 'upperLimit': '56'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': '61'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student's t tests or Wilcoxon signed rank tests.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Participants were admitted to the Clinical Research Units at 06:00-08:00 hours after an overnight fast. Euglycaemic-hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm-2 min-1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.', 'unitOfMeasure': 'percent change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was performed on all participants with available baseline and final clamp studies'}, {'type': 'SECONDARY', 'title': 'Glucose Area Under the Curve in These Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '8.98', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '8.74', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'unitOfMeasure': 'mmol/l/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis was performed on all participants with available baseline and final clamp studies'}, {'type': 'SECONDARY', 'title': 'Plasma CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'title': 'Change in CRP at 8 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '4.1'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '4.5'}]}]}, {'title': 'Change in CRP at 12 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '3.6'}, {'value': '-.3', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma C-reactive protein was measured by PVAHS clinical laboratory. Data are reported as change from baseline at 8 and 12 weeks.', 'unitOfMeasure': 'mg/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication'}, {'type': 'SECONDARY', 'title': 'Endothelial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'title': 'Pat Index baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '.5', 'groupId': 'OG001'}]}]}, {'title': 'Pat Index 12 week', 'categories': [{'measurements': [{'value': '1.7', 'spread': '.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Endothelial-mediated arterial responses using peripheral arterial tonometry (PAT; Itamar Medical, Caesarea, Israel).', 'unitOfMeasure': 'index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants with available baseline and final clamp studies'}, {'type': 'SECONDARY', 'title': 'Plasma Interleukin 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'title': 'Change in IL-6 at 8 weeks', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.4'}]}]}, {'title': 'Change in IL-6 at 12 weeks', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '0.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma IL-6 was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication'}, {'type': 'SECONDARY', 'title': 'Plasma sVCAM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'title': 'Change in sVCAM at 8 weeks', 'categories': [{'measurements': [{'value': '-12', 'groupId': 'OG000', 'lowerLimit': '-162', 'upperLimit': '75'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-105', 'upperLimit': '272'}]}]}, {'title': 'Change in sVCAM at 12 weeks', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '-145', 'upperLimit': '166'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '320'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma soluble VCAM was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication'}, {'type': 'SECONDARY', 'title': 'Plasma Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Matching placebo'}, {'id': 'OG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate: Salsalate therapy'}], 'classes': [{'title': 'Change in adiponectin at 8 weeks', 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '0.3'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '2.1'}]}]}, {'title': 'Change in adiponectin at 12 weeks', 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1.7'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '2.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma soluble Adiponectin was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.', 'unitOfMeasure': 'μg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching placebo'}, {'id': 'FG001', 'title': 'Salsalate', 'description': 'Salsalate therapy (Caraco Pharmaceutical Labs, Detroit, MI, USA) was initiated at 3.0 g/day and increased at weeks 2 and 4 of the treatment period to 3.5 and 4.0 g/day, respectively, in divided doses twice daily, as tolerated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Received Study Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants were veterans aged 21-75 years with impaired fasting glucose (i.e. ≥5.6 but \\<7 mmol/l) or impaired glucose tolerance (2 h glucose values ≥7.8 but \\<11.1 mmol/l) during a standard 2 h 75 g OGTT. Study participants were recruited from clinics and hospitals throughout the Phoenix and Boston VA Health Care systems.', 'preAssignmentDetails': 'After enrolment there were 1 week screening, 3 week single-masked placebo run-in (to assess compliance) and 12 week randomised, double-masked treatment periods, with participants randomised 1:1 to receive salsalate or placebo. 78 individuals entered the run-in phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching placebo'}, {'id': 'BG001', 'title': 'Salsalate Therapy', 'description': 'Salsalate therapy, double-masked. Salsalate (Caraco Pharmaceutical Labs, Detroit, MI, USA) was initiated at 3.0 g/day and increased at weeks 2 and 4 of the treatment period to 3.5 and 4.0 g/day, respectively, in divided doses twice daily, as tolerated for 12 weeks total.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '9', 'groupId': 'BG000'}, {'value': '60', 'spread': '6', 'groupId': 'BG001'}, {'value': '58', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin sensitivity', 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'spread': '1.46', 'groupId': 'BG000'}, {'value': '3.8', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '3.93', 'spread': '1.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of euglycemic-hyperinsulinemic clamp.', 'unitOfMeasure': 'mg/ kg . min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Oral Glucose Tolerance Test', 'classes': [{'categories': [{'measurements': [{'value': '167', 'spread': '21', 'groupId': 'BG000'}, {'value': '165', 'spread': '17', 'groupId': 'BG001'}, {'value': '166', 'spread': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Area Under the Curve Measurement', 'unitOfMeasure': 'mg/dl. min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '105', 'spread': '12', 'groupId': 'BG000'}, {'value': '103', 'spread': '10', 'groupId': 'BG001'}, {'value': '104', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2006-05-26', 'resultsFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2006-05-26', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-15', 'studyFirstPostDateStruct': {'date': '2006-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systemic Glucose Disposal- Glucose Infusion Rates', 'timeFrame': '3 months', 'description': 'Participants were admitted to the Clinical Research Units at 06:00-08:00 hours after an overnight fast. Euglycaemic-hyperinsulinaemic clamps were conducted at baseline and at the end of the study. Because salsalate therapy appears to decrease insulin clearance leading to higher circulating insulin levels during the clamp, we reduced the infusion rate of insulin in the active treatment arm by 20% (from 100 to 80 mUm-2 min-1) at the study end. Insulin solutions were prepared by the site pharmacist so that study staff remained blinded to drug assignment. Whole-body insulin sensitivity was estimated from glucose infusion rate (GIR) during last 30 min of insulin infusions.'}], 'secondaryOutcomes': [{'measure': 'Glucose Area Under the Curve in These Subjects', 'timeFrame': '3 months'}, {'measure': 'Plasma CRP', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma C-reactive protein was measured by PVAHS clinical laboratory. Data are reported as change from baseline at 8 and 12 weeks.'}, {'measure': 'Endothelial Function', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Endothelial-mediated arterial responses using peripheral arterial tonometry (PAT; Itamar Medical, Caesarea, Israel).'}, {'measure': 'Plasma Interleukin 6', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma IL-6 was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.'}, {'measure': 'Plasma sVCAM', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma soluble VCAM was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.'}, {'measure': 'Plasma Adiponectin', 'timeFrame': '8 and 12 weeks', 'description': 'Plasma soluble Adiponectin was measured by ELISA. Data are reported as change from baseline at 8 and 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiovascular Disease', 'Inflammation', 'Insulin Resistance', 'Type 2 DM'], 'conditions': ['Atherosclerosis', 'Cardiovascular Disease', 'Inflammation', 'Insulin Resistance', 'Noninsulin-dependent Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '23370525', 'type': 'RESULT', 'citation': 'Goldfine AB, Conlin PR, Halperin F, Koska J, Permana P, Schwenke D, Shoelson SE, Reaven PD. A randomised trial of salsalate for insulin resistance and cardiovascular risk factors in persons with abnormal glucose tolerance. Diabetologia. 2013 Apr;56(4):714-23. doi: 10.1007/s00125-012-2819-3. Epub 2013 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications.\n\nThe objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.', 'detailedDescription': 'Recent studies demonstrate an important role for sub-acute, chronic inflammation in the development of insulin resistance, type 2 diabetes mellitus (T2 DM) and cardiovascular disease (CVD). A broad body of data indicate that obesity and high fat or "Western" diets activate sub-acute inflammatory processes in fat and liver tissue as well as in mononuclear cells. The inflammatory mediators produced by these tissues and cells promote the development of insulin resistance both locally and at distant sites such as skeletal muscle. These same inflammatory mediators may also increase the risk for CVD. Work from our labs indicate that Nuclear Factor-kappa B (NF-kB), an inflammatory master switch for a multitude of proinflammatory genes and pathways, is activated in fat and liver by obesity and high fat diets. We have also noted similar NF-kB activation in monocytes and macrophages in similar conditions of nutritional excess. It has become evident that salicylates inhibit the NF-kB regulatory protein IKKB (inhibitor of Kappa B Kinase) and we have subsequently demonstrated their ability to downregulate NF-kB activation in each of these above tissues in animals. Moreover, by inhibiting the IKKB/NF-kB pathway, salicylates appear to ameliorate insulin resistance and its associated metabolic abnormalities and potentially provide a new approach for pharmacologic treatment of T2 DM as well as individuals with conditions such as impaired glucose intolerance (IGT) to prevent their progression to diabetes. Preliminary results from a two-week trail is T2 DM patients indicated that high-dose aspirin(ASA,\\~7g/day) improved glucose metabolism and associated risk factors. While this was as important first step towards proof-of-principle, the risk of severe gastrointestinal bleeding associated with high-dose ASA precludes broader use. Salicylate in its prodrug form of salsalate(Disalcid), is much safer than ASA(as it does not irritate the gastric mucosa nor alter bleeding times). We have now conducted several preliminary short-term in individuals with IGT or T2 DM as well in obese insulin resistant subjects and have demonstrated that salsalate in doses of 3.5-4.5g/d provides similar blood salicylate levels as high dose ASA and induces similar clinical and metabolic benefits over the 2-4 weeks study duration. Therefore, in vitro, animal and human clinical studies all support the concept that inhibiting the IKKB/NF-kB pathway with salsalate is a feasible approach to reducing insulin resistance. This study will more fully characterize the metabolic benefits of high dose salsalate therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female veterans between the age of 21-75 who have IFG (impaired fasting glucose) and/or IGT\n\nExclusion Criteria:\n\n* any diabetes therapy in the prior 12-months period\n* any acute illness\n* Ongoing high dose aspirin or Salsalate Therapy\n* history of GI bleeding\n* hearing problems\n* poor vascular access, prior pancreatitis, uncontrolled hypertension, pregnancy, renal disease or anemia'}, 'identificationModule': {'nctId': 'NCT00330733', 'briefTitle': 'Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'CLIN-011-05F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salsalate Therapy', 'description': 'Salsalate', 'interventionNames': ['Drug: Salsalate']}], 'interventions': [{'name': 'Salsalate', 'type': 'DRUG', 'otherNames': ['Amigesic', 'Anaflex', 'Argesic-SA', 'Disalcid', 'Marthritic', 'Mono-Gesic', 'Salflex', 'Salsitab'], 'description': 'Participants were randomized to 12-week treatment with up to 4 g/day.', 'armGroupLabels': ['Salsalate Therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants were randomized to 12-week treatment matching the active salsalate arm.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Carl T. Hayden VA Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Peter Reaven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carl T. Hayden VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Joslin Diabetes Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}