Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT02008968
Status:
UNKNOWN
Last Update Posted:
2013-12-11
First Post:
2013-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Allopurinol Treatment on Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-12-07', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in insulin resistance (HOMA-IR)', 'timeFrame': 'baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperuricemia', 'Prediabetes', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. However none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. With this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 30\n* Serum uric acid level ≥7mg/dL\n* Glomerular filtration rate ≥60 ml/min\n\nExclusion Criteria:\n\n* presence of Diabetes Mellitus\n* history of gout\n* history of allopurinol use\n* body mass index ≥35 kg/m2\n* proteinuria ≥ 1gr/ day\n* presence of autoimmune disease\n* rheumatology associated disease\n* presence of hypothyroidism or hyperthyroidism\n* presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)'}, 'identificationModule': {'nctId': 'NCT02008968', 'briefTitle': 'Effect of Allopurinol Treatment on Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'orgStudyIdInfo': {'id': 'Allo2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Uric acid ≥7 mg/dL', 'description': 'This arm will receive allopurinol treatment. 50 subjects will be recruited.', 'interventionNames': ['Drug: allopurinol 300 mg./day']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Uric acid ≥6 and <7', 'description': 'This arm will not receive allopurinol. 50 subjects will be recruited.', 'interventionNames': ['Other: No intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normouricemic', 'description': 'This arm is healthy controls. 30 subjects will be recruited.', 'interventionNames': ['Drug: Normouricemic']}], 'interventions': [{'name': 'allopurinol 300 mg./day', 'type': 'DRUG', 'armGroupLabels': ['Uric acid ≥7 mg/dL']}, {'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Uric acid ≥6 and <7']}, {'name': 'Normouricemic', 'type': 'DRUG', 'armGroupLabels': ['Normouricemic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34353', 'city': 'Istanbul', 'state': 'Marmara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Kanbay, Associate Professor', 'role': 'CONTACT', 'email': 'drkanbay@yahoo.com', 'phone': '+902165709294'}, {'name': 'Mehmet Kanbay', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istanbul Medeniyet University Goztepe Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Mehmet Kanbay, Associate Professor', 'role': 'CONTACT', 'email': 'drkanbay@yahoo.com', 'phone': '+902165709294'}], 'overallOfficials': [{'name': 'Ali Bakan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Medeniyet University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor Mehmet Kanbay', 'investigatorFullName': 'Mehmet Kanbay', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}