We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741702
First Posted: August 26, 2008
Last Update Posted: May 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by (Responsible Party):
Sheldon Tobe, Sunnybrook Health Sciences Centre
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Further study details as provided by Sheldon Tobe, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • systolic blood pressure [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Sheldon Tobe, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00741702     History of Changes
Other Study ID Numbers: 231-2001
First Submitted: August 25, 2008
First Posted: August 26, 2008
Last Update Posted: May 16, 2012
Last Verified: May 2012

Keywords provided by Sheldon Tobe, 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