- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00572403
Risk Factors Contributing to the Development of Microalbuminuria
March 4, 2011 updated by: Sunnybrook Health Sciences Centre
Risk Factors Contributing to the Development of Microalbuminuria Over a 5 Year Period
This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project.
We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index.
The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.
Study Overview
Status
Completed
Conditions
Detailed Description
The primary objective of this research project is to determine risk factors related to the development of microalbuminuria.
The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria.
Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria.
Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Health Sciences Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants returning for a 4-5 year follow-up visit as part of an ongoing research project will be screened for microalbuminuria and invited to participate if they meet the appropriate criteria.
Description
Inclusion Criteria:
- participation in the Double Exposure study
- elevated microalbuminuria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine risk factors related to the development of microalbuminuria.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sheldon Tobe, MD, FRCPC, Sunnybrook Health Sciences Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 12, 2007
First Posted (Estimate)
December 13, 2007
Study Record Updates
Last Update Posted (Estimate)
March 8, 2011
Last Update Submitted That Met QC Criteria
March 4, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 298-2007
- IISP#P2350
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Microalbuminuria
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University Medical Center GroningenNetherlands Heart Foundation; Dutch Kidney FoundationCompletedCardiovascular Diseases | Microalbuminuria | Renal Disease
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Shanghai Zhongshan HospitalUnknownHypertension | Microalbuminuria
-
The Second Hospital of Nanjing Medical UniversityUnknownMicroalbuminuria | Microalbuminuria /Creatinine Ratios ACR
-
Sunnybrook Health Sciences CentreServierCompletedDiabetes | MicroalbuminuriaCanada
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The University of The West IndiesCaribbean Health Research CouncilUnknownMicroalbuminuria | Sickle Cell NephropathyJamaica
-
Charles Drew University of Medicine and ScienceCompletedMicroalbuminuriaUnited States
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GlaxoSmithKlineTerminatedHeart Failure, Congestive and MicroalbuminuriaUnited States, Canada, Puerto Rico
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Eastern Virginia Medical SchoolWithdrawnPreeclampsia | MicroalbuminuriaUnited States
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The First Affiliated Hospital with Nanjing Medical...UnknownMicroalbuminuria | Contrast-induced Acute Kidney InjuryChina
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Steno Diabetes Center CopenhagenBristol-Myers Squibb; Sanofi-SynthelaboCompletedHypertension | Type 2 Diabetes | Microalbuminuria