Status:
COMPLETED
Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Pfizer
Conditions:
Hypertension
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 peo...
Detailed Description
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 prede...
Eligibility Criteria
Inclusion
- Age\>= 18 yr
- Type 2 diabetes mellitus
- Persistent hypertension (systolic pressure \>= 130 mmHg, diastolic pressure \>= 80 mm Hg, or both)
Exclusion
- use of beta blocker
- women of child-bearing age not able to use a reliable method of birth control
- Connective tissue disorder
- Severe systemic or malignant disease
- Inability to follow the protocol
- Bilateral renal artery stenosis and other causes of secondary hypertension
- Serum creatinine level \> 250 micromol/L
- cerebrovascular even within 6 mo
- valvular heart disease
- unstable angina
- Myocardial infarction
- Revascularization procedure within 3 mo before study recruitment
- heart failure
- cardiac arrhythmia requiring medical treatment or heart block
- active hepatic disease
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00741702
Start Date
September 1 2001
End Date
March 1 2003
Last Update
May 16 2012
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