Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 3:39 PM
Study NCT ID:
NCT00898950
Status:
COMPLETED
Last Update Posted:
2009-05-12
First Post:
2009-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-11', 'studyFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2009-05-11', 'lastUpdatePostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in inflammatory markers', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'aspirin', 'oxidative stress', 'insulin resistance', 'endothelial function', 'inflammation', 'photoplethysmography', 'dysglycaemia'], 'conditions': ['Diabetes Type 2']}, 'referencesModule': {'references': [{'pmid': '24372992', 'type': 'DERIVED', 'citation': 'Raghavan RP, Laight DW, Cummings MH. Aspirin in type 2 diabetes, a randomised controlled study: effect of different doses on inflammation, oxidative stress, insulin resistance and endothelial function. Int J Clin Pract. 2014 Feb;68(2):271-7. doi: 10.1111/ijcp.12310. Epub 2013 Dec 22.'}]}, 'descriptionModule': {'briefSummary': "This study was set up to assess the effects of different doses of aspirin when compared with placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out (rest period) in between, in people with type-2 diabetes and high cardiovascular risk. Specifically, its effects on different factors which are thought to contribute to diabetes such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess glucose in the blood), oxidative stress (effects from accumulation of by-products of metabolism), endothelial function (function of lining of blood vessels) and inflammation were studied."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes type 2\n* age \\> 18 and \\< 70\n* high cardiovascular risk\n\nExclusion Criteria:\n\n* presence of active/established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease)\n* insulin treatment\n* patients with known peptic ulcer disease or those on anti-coagulation\n* significant renal impairment\n* aspirin intolerance\n* use of anticoagulants\n* significant liver disease'}, 'identificationModule': {'nctId': 'NCT00898950', 'briefTitle': 'Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Portsmouth'}, 'officialTitle': 'The Links Between Dysglycaemia, Insulin Resistance, Endothelial Function, Inflammation and Oxidative Stress: Effect of Different Doses of Aspirin in Subjects With Type-2 Diabetes and High Cardiovascular Risk', 'orgStudyIdInfo': {'id': '2004-001418-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin low dose', 'description': 'Effects of using aspirin 75 mgs/day for 2 weeks.', 'interventionNames': ['Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Aspirin medium dose', 'description': 'Effects of using aspirin 300 mgs/day', 'interventionNames': ['Drug: Aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin high dose', 'description': 'aspirin 900mgs QID orally for 2 weeks', 'interventionNames': ['Drug: Aspirin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Other: placebo tablet']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['acetyl salicylic acid'], 'description': 'Aspirin 75mgs/day orally for 2 weeks.', 'armGroupLabels': ['Aspirin low dose']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['acetyl salicylic acid'], 'description': '300mgs/day orally for 2 weeks', 'armGroupLabels': ['Aspirin medium dose']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['acetyl salicylic acid'], 'description': 'aspirin 900mgs QID orally for 2 weeks', 'armGroupLabels': ['aspirin high dose']}, {'name': 'placebo tablet', 'type': 'OTHER', 'description': 'placebo tablet with lactose and excipients.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO1 2DT', 'city': 'Portsmouth', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'School of Pharmacy and Biomedical Sciences, University of Posrtmouth', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}], 'overallOfficials': [{'name': 'Rajeev P Raghavan, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Portsmouth Hospitals NHS Trust'}, {'name': 'Michael H Cummings, MD, FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Portsmouth Hospitals NHS TRust & University of Portsmouth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Portsmouth', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr MH Cummings', 'oldOrganization': 'Portsmouth Hospitals NHS Trust & University of Portsmouth'}}}}