Official Title: “Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2003

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.

Intervention(s) in this Clinical Trial

• Other: Nurse administered treatment algorithm
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Intervention group
  • A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.
• No Intervention: Control group
  • Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care.

Primary Measures

• systolic blood pressure
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events
  • Time Frame: 12 months
    Safety Issue?: Yes

Inclusion Criteria:

• Age>= 18 yr
• Type 2 diabetes mellitus
• Persistent hypertension (systolic pressure >= 130 mmHg, diastolic pressure >= 80 mm
• Hg, or both)

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sunnybrook Health Sciences Centre

Overall Clinical Trial Officials and Contacts

Sheldon Tobe, MD, FRCPC Principal Investigator Sunnybrook Health Sciences Centre  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00741702

Study ID Number: 231-2001

ClinicalTrials.gov Identifier: NCT00741702

Health Authority: Canada: Ethics Review Committee