Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT01931527
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2013-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C469709', 'term': 'rasburicase'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'efabbrini@dom.wustl.edu', 'phone': '314-362-8156', 'title': 'Elisa Fabbrini, MD, PhD', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Increase in Insulin-stimulated Glucose Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m\\^2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m\\^2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'title': 'BASAL Insulin Sensitivity', 'categories': [{'measurements': [{'value': '231', 'spread': '23', 'groupId': 'OG000'}, {'value': '162', 'spread': '24', 'groupId': 'OG001'}]}]}, {'title': 'AFTER RASBURICASE Insulin Sensitivity', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Rasburicase infusion to lower uric acid was only administered to subjects in the High Uric Acid group', 'groupId': 'OG000'}, {'value': '156', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.', 'unitOfMeasure': '% incr. in insulin-mediated gluc. uptake', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Effect of Reducing Uric Acid on Oxidative Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m\\^2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m\\^2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'title': 'BASELINE urinary isoprostanes', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'AFTER RASBURICASE isoprostanes', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Rasburicase infusion to reduce uric acid was administered only to the High Uric Acid group', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction. Levels of isoprostanes were normalized to urinary creatinine and reported at ng/mg.', 'unitOfMeasure': 'ng/mg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Carbonylated Protein Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'categories': [{'measurements': [{'value': '929', 'spread': '86', 'groupId': 'OG000'}, {'value': '680', 'spread': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before reducing uric acid', 'description': 'Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AFTER Rasburicase Carbonylated Protein Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'categories': [{'measurements': [{'value': '1085', 'spread': '131', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis only completed on subjects in the High Uric Acid group'}, {'type': 'SECONDARY', 'title': 'Baseline Plasma TRAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before reducing uric acid', 'description': 'Total Radical-Trapping Antioxidant Potential', 'unitOfMeasure': 'mmol · Lˉ¹', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AFTER Rasburicase Plasma TRAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Total Radical-Trapping Antioxidant Potential', 'unitOfMeasure': 'mmol · Lˉ¹', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AFTER rasburicase plasma Total Radical-Trapping Antioxidant Potential (TRAP) was only measured in the subjects with high uric acid'}, {'type': 'SECONDARY', 'title': 'Baseline Plasma FRAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m² with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m² with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before reducing uric acid', 'description': 'Ferric-Reducing Antioxidant Potential', 'unitOfMeasure': 'mmol Fe⁺² · Lˉ¹', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'OG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Ferric-Reducing Antioxidant Potential', 'unitOfMeasure': 'mmol Fe⁺² · Lˉ¹', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'AFTER rasburicase plasma FRAP only measured in subjects with high uric acid'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Obese Subjects With Normal Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with normal uric acid (= or \\< 5 mg/dL)'}, {'id': 'FG001', 'title': 'Obese Subjects With High Uric Acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m2 with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min\n\nRasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Uric Acid', 'description': '16 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid \\<5mg/dL'}, {'id': 'BG001', 'title': 'High Uric Acid', 'description': '15 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid \\>6mg/dL'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '37.1', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plasma uric acid concentration', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '7.1', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Obese subjects with low uric acid (\\<5mg/dL)'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2013-08-23', 'resultsFirstSubmitDate': '2015-04-28', 'studyFirstSubmitQcDate': '2013-08-23', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-28', 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Increase in Insulin-stimulated Glucose Uptake', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.'}], 'secondaryOutcomes': [{'measure': 'The Effect of Reducing Uric Acid on Oxidative Status', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction. Levels of isoprostanes were normalized to urinary creatinine and reported at ng/mg.'}, {'measure': 'Baseline Carbonylated Protein Ratio', 'timeFrame': 'Before reducing uric acid', 'description': 'Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle'}, {'measure': 'AFTER Rasburicase Carbonylated Protein Ratio', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle'}, {'measure': 'Baseline Plasma TRAP', 'timeFrame': 'Before reducing uric acid', 'description': 'Total Radical-Trapping Antioxidant Potential'}, {'measure': 'AFTER Rasburicase Plasma TRAP', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Total Radical-Trapping Antioxidant Potential'}, {'measure': 'Baseline Plasma FRAP', 'timeFrame': 'Before reducing uric acid', 'description': 'Ferric-Reducing Antioxidant Potential'}, {'measure': 'AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)', 'timeFrame': '12 hours after reducing uric acid', 'description': 'Ferric-Reducing Antioxidant Potential'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Metabolic syndrome', 'Hyperuricemia'], 'conditions': ['Obesity', 'Metabolic Syndrome', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.', 'detailedDescription': "It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese (BMI 30-45 kg/m²);\n* serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)\\],\n\nExclusion Criteria:\n\n* renal dysfunction (serum creatinine \\>1.5 mg/dL);\n* pregnancy or lactating;\n* take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates;\n* history of xanthinuria, type 2 diabetes or other significant organ system dysfunction;\n* have G6PD deficiency;\n* use hormone-replacement or oral-contraceptive therapy;\n* smoke tobacco;\n* anemic (Hb \\<10 g/dl)'}, 'identificationModule': {'nctId': 'NCT01931527', 'acronym': 'UA', 'briefTitle': 'Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Effect of Plasma Uric Acid on Insulin Sensitivity, Endothelial Function and Inflammation', 'orgStudyIdInfo': {'id': '06-0509 / 201104189'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Obese subjects with normal uric acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m² with normal uric acid (= or \\< 5 mg/dL)'}, {'type': 'EXPERIMENTAL', 'label': 'Obese subjects with high uric acid', 'description': 'Subjects with a body mass index = or \\> 30 kg/m² with high uric acid (\\>6 mg/dL)\n\nIntervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min', 'interventionNames': ['Drug: Rasburicase']}], 'interventions': [{'name': 'Rasburicase', 'type': 'DRUG', 'otherNames': ['Elitek'], 'description': 'one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min', 'armGroupLabels': ['Obese subjects with high uric acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Samuel Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}