Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

NCT00741702 | Completed

• 1 other identifier: 231-2001
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Diabetes Mellitus

Keywords

Hypertension; Type 2 diabetes; First Nations populations

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

  12 months

Secondary Outcomes (1)

• Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: Nurse administered treatment algorithm

Control group

NO INTERVENTION

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

Interventions

Nurse administered treatment algorithm 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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Pfizer: collaborator

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sheldon Tobe, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: September 1, 2001
• Primary Completion: March 1, 2003
• Study Completion: March 1, 2003
• Last Updated: May 16, 2012

Record last verified: 2012-05