Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples (DREAM3)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by (Responsible Party):
Sheldon Tobe, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00741702
First received: August 25, 2008
Last updated: May 15, 2012
Last verified: May 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Resource links provided by NLM:


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
Experimental: Intervention group
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
No Intervention: Control group
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

No publications provided

Responsible Party: Sheldon Tobe, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00741702     History of Changes
Other Study ID Numbers: 231-2001
Study First Received: August 25, 2008
Last Updated: May 15, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Hypertension
Type 2 diabetes
First Nations populations

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014