Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples - Full Text View

Sponsors and Collaborators:	Sunnybrook Health Sciences Centre Canadian Institutes of Health Research (CIHR) Pfizer
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00741702

Purpose

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.

Condition	Intervention
Hypertension Diabetes Mellitus	Other: Nurse administered treatment algorithm

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	95
Study Start Date:	September 2001
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741702

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Canadian Institutes of Health Research (CIHR)

Pfizer

Investigators

Principal Investigator:

Sheldon Tobe, MD, FRCPC

Sunnybrook Health Sciences Centre

More Information

Responsible Party:	Sunnybrook Health Sciences Centre ( Sheldon Tobe )
Study ID Numbers:	231-2001
Study First Received:	August 25, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741702
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:

Hypertension
Type 2 diabetes
First Nations populations

Study placed in the following topic categories:

Verapamil
Metabolic Diseases
Diltiazem
Diabetes Mellitus, Type 2
Irbesartan
Vascular Diseases

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009