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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
History of Changes

August 25, 2008
May 15, 2012
September 2001
March 2003   (final data collection date for primary outcome measure)
systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00741702 on ClinicalTrials.gov Archive Site
Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples
Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Diabetes Mellitus
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
  • Experimental: Intervention group
    A home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy.
    Intervention: Other: Nurse administered treatment algorithm
  • No Intervention: Control group
    Treatment decisions were made by each subject's primary care physician. Participants in this group received usual care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
March 2003
March 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00741702
231-2001
No
Sheldon Tobe, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
  • Canadian Institutes of Health Research (CIHR)
  • Pfizer
Principal Investigator: Sheldon Tobe, MD, FRCPC Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP