Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

NCT ID: NCT00741702

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2003-03-31

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 people with existing hypertension and type 2 diabetes.

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 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.

Conditions

Hypertension; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.

Group Type: EXPERIMENTAL

Nurse administered treatment algorithm

Intervention Type: OTHER

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

Control group

Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Sheldon Tobe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheldon Tobe, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Other Identifiers

231-2001

Identifier Type: -

Identifier Source: org_study_id