Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-29 @ 12:10 PM
Study NCT ID:
NCT00639756
Status:
COMPLETED
Last Update Posted:
2008-10-13
First Post:
2008-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Allopurinol on Insulin Resistance and Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-10', 'studyFirstSubmitDate': '2008-03-10', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance (HOMA index)', 'timeFrame': '2 weeks'}, {'measure': 'Blood pressure', 'timeFrame': '2 weeks'}, {'measure': 'Triglycerides, HDL cholesterol', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Adiponectin', 'timeFrame': '2 weeks'}, {'measure': 'Leptin', 'timeFrame': '2 weeks'}, {'measure': 'CRP level', 'timeFrame': '2 weeks'}, {'measure': 'Weight gain', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uric acid', 'Fructose', 'Hypertension', 'Insulin', 'Glucose', 'HOMA'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '30409184', 'type': 'DERIVED', 'citation': 'Johnson RJ, Perez-Pozo SE, Lillo JL, Grases F, Schold JD, Kuwabara M, Sato Y, Hernando AA, Garcia G, Jensen T, Rivard C, Sanchez-Lozada LG, Roncal C, Lanaspa MA. Fructose increases risk for kidney stones: potential role in metabolic syndrome and heat stress. BMC Nephrol. 2018 Nov 8;19(1):315. doi: 10.1186/s12882-018-1105-0.'}, {'pmid': '20029377', 'type': 'DERIVED', 'citation': 'Perez-Pozo SE, Schold J, Nakagawa T, Sanchez-Lozada LG, Johnson RJ, Lillo JL. Excessive fructose intake induces the features of metabolic syndrome in healthy adult men: role of uric acid in the hypertensive response. Int J Obes (Lond). 2010 Mar;34(3):454-61. doi: 10.1038/ijo.2009.259. Epub 2009 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'Studies in animals have found that allopurinol can markedly improve fructose induced metabolic syndrome. In this study we test the hypothesis that allopurinol may lower BP, reduce triglycerides, and improve metabolic parameters in subjects placed on a high fructose diet.', 'detailedDescription': '60 male subjects, age 40 to 65 years of age, will be placed on a 3500kcal (55% carbohydrates containing 200 g fructose) for 2 weeks. Half will receive allopurinol mg/day (randomized). At the end of 2 weeks we measure a variety of parameters including fasting glucose and insulin levels (with calculation of HOMA index), serum lipids (including triglycerides and LDL/HDL cholesterol), sitting blood pressure, serum uric acid, weight, and various other measurements (C reactive protein, adiponectin and leptin levels, and urate redox products). Primary endpoint is insulin resistance. Secondary endpoints are blood pressure, lipids, uric acid, weight.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males, age 40 -65 yrs\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00639756', 'briefTitle': 'The Effect of Allopurinol on Insulin Resistance and Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Mateo Orfila'}, 'officialTitle': 'Phase 2 Study to Determine if Allopurinol Blocks Features of Metabolic Syndrome Induced by Fructose Ingestion', 'orgStudyIdInfo': {'id': 'IbSalut-M-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Allopurinol given for 2 weeks with diet', 'interventionNames': ['Drug: Allopurinol']}], 'interventions': [{'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Allopurinol 300 mg', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given for 2 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07703', 'city': 'Menorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Renal Unit, Mateo Orfila Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Mateo Orfila', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'PEREZ-POZO, SANTOS E. LOPEZ-LILLO, JULIAN. JOHNSON, RICHARD', 'oldOrganization': 'MATEO ORFILA HOSPITAL, University of Florida'}}}}