An interventional study of Insulin and No Insulin in Orthostatic Hypotension, Diabetes and Syncope, sponsored by University of British Columbia. Withdrawn at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by University of British Columbia · Not applicable, Interventional, and Diagnostic
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.
Before and 2 weeks after the start of standard insulin therapy several tests will be done:
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
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Exclusion Criteria:
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.
Other: No Insulin
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.
Other: 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.
Also known as: Lantus
Study session will occur prior to initiation of insulin therapy.
1. Presence or absence of orthostatic hypotension
defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
Time frame: 1 day
1. The nadir of middle cerebral artery (MCA) velocity
lowest middle cerebral artery flow velocity determined by transcranial Doppler
Time frame: 1 day
2. The presence or absence of a positive augmented tilt table test
The augmented tilt table test will occur after receiving 300 μg nitroglycerin (GTN), and is a recognized method of testing for risk of vasovagal syncope. The tilt table will be considered positive and aborted prior to the 20 minutes if the subjects have a syncopal spell or demonstrate presyncopal (lightheadedness) symptoms in association with a 30 mm Hg drop in systolic blood pressure.
Time frame: 1 day
3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.
lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of British Columbia