Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-06 @ 9:56 PM
Study NCT ID:
NCT00572403
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2007-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors Contributing to the Development of Microalbuminuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-04', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-12', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine risk factors related to the development of microalbuminuria.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria.', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['microalbuminuria', 'risk factors'], 'conditions': ['Microalbuminuria']}, 'descriptionModule': {'briefSummary': 'This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.', 'detailedDescription': 'The primary objective of this research project is to determine risk factors related to the development of microalbuminuria. The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants returning for a 4-5 year follow-up visit as part of an ongoing research project will be screened for microalbuminuria and invited to participate if they meet the appropriate criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participation in the Double Exposure study\n* elevated microalbuminuria'}, 'identificationModule': {'nctId': 'NCT00572403', 'briefTitle': 'Risk Factors Contributing to the Development of Microalbuminuria', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Risk Factors Contributing to the Development of Microalbuminuria Over a 5 Year Period', 'orgStudyIdInfo': {'id': '298-2007'}, 'secondaryIdInfos': [{'id': 'IISP#P2350'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Sheldon Tobe, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Frosst Canada Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Sheldon Tobe', 'oldOrganization': 'Sunnybrook Health Sciences Centre'}}}}