NCT01914146|Withdrawn
Study Stopped
Study was changed to Insulin, hypotension and sarcopenia
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Study was changed to Insulin, hypotension and sarcopenia
Sponsor study identifier
interventional
0
1 country
1
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2, 2018
Actual (reported)Study Completion
January 2, 2018
Actual (reported)In the proposed study, the investigators examine in older adults with Type 2 diabetes the impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the response of arterial blood pressure and Doppler measures of cerebral blood flow during upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not present at baseline.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 22, 2013
Actual (reported)August 1, 2013
Actual (reported)April 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 2, 2018
Actual (reported)January 2, 2018
Actual (reported)1. Presence or absence of orthostatic hypotension
defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
1 day
1. The nadir of middle cerebral artery (MCA) velocity
1 day
2. The presence or absence of a positive augmented tilt table test
1 day
Study sessions will occur before the initiation of insulin therapy (no insulin). Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.
Study session will take place 2-4 weeks after the initiation of insulin therapy. Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.
Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.
Study session will occur prior to initiation of insulin therapy.
Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue
Vancouver, British Columbia, V5Z 1M9, Canada
Kenneth M Madden, MD
University of British Columbia
0 participants (actual enrollment reported by the registry).
First Submitted
July 22, 2013
First Posted
August 1, 2013
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
The Effect of Water Carbonation on Orthostatic Tolerance
3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.
1 day
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Primary Completion
January 2, 2018
Actual (reported)Study Completion
January 2, 2018
Actual (reported)Last Updated
January 10, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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