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Completed

NCT Number: NCT00741702

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. systolic blood pressure

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Pfizer

Registry information

Acronym: DREAM3

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Aug 26, 2008
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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