Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT00741702
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2008-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2008-08-25', 'studyFirstSubmitQcDate': '2008-08-25', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systolic blood pressure', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Type 2 diabetes', 'First Nations populations'], 'conditions': ['Hypertension', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.', 'detailedDescription': "Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>= 18 yr\n* Type 2 diabetes mellitus\n* Persistent hypertension (systolic pressure \\>= 130 mmHg, diastolic pressure \\>= 80 mm Hg, or both)\n\nExclusion Criteria:\n\n* use of beta blocker\n* women of child-bearing age not able to use a reliable method of birth control\n* Connective tissue disorder\n* Severe systemic or malignant disease\n* Inability to follow the protocol\n* Bilateral renal artery stenosis and other causes of secondary hypertension\n* Serum creatinine level \\> 250 micromol/L\n* cerebrovascular even within 6 mo\n* valvular heart disease\n* unstable angina\n* Myocardial infarction\n* Revascularization procedure within 3 mo before study recruitment\n* heart failure\n* cardiac arrhythmia requiring medical treatment or heart block\n* active hepatic disease'}, 'identificationModule': {'nctId': 'NCT00741702', 'acronym': 'DREAM3', 'briefTitle': 'Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples', 'orgStudyIdInfo': {'id': '231-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.', 'interventionNames': ['Other: Nurse administered treatment algorithm']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care."}], 'interventions': [{'name': 'Nurse administered treatment algorithm', 'type': 'OTHER', 'description': 'Start with Irbesartan 150 mg/d; check BP in 6 wks, if BP \\>=130/80 mm HF, 300 mg/d irbesartan; check BP at next visit, if BP\\>= 130/80 mm Hg, add HCTZ 12.5 mg/d; check BP at next visit, if BP\\>=130/80 mm Hg, add verapamil 180 mg/d; check BP at next visit, if BP\\>=13/80 mm Hg, increase verapamil to 240 mg/d', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'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': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sheldon Tobe', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}