Insulin Therapy and Falls Due to Orthostatic Hypotension
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.
Drug: Insulin ( Lantus)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)|
- 1. Presence or absence of orthostatic hypotension [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
- 1. The nadir of middle cerebral artery (MCA) velocity [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]lowest middle cerebral artery flow velocity determined by transcranial Doppler
- 2. The presence or absence of a positive augmented tilt table test [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]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.
- 3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Start of Insulin Therapy
Standard Insulin Therapy. Measurements will be taken before and 2 weeks after the initiation of the Therapy.
Drug: Insulin ( Lantus)
Standard Insulin Therapy will be prescribed by the diabetologist. Testing will be done pre and post start of the insulin therapy.
Other Name: Lantus
Before and 2 weeks after the start of standard insulin therapy several tests will be done:
- orthostatic hypotension will be tested for with 3 orthostatic maneuvers
- vasovagal syncope will be tested with 2 tilt table tests, one augmented with 400ug of nitroglycerin
- MCA velocity will be measured with a transcranial doppler
- Heart Rate and Blood Pressure will be measured throughout the test with a Finometer and Power Lab on a beat to beat basis
|Canada, British Columbia|
|UBC VITALiTY Research, Dept. of Medicine, Vancouver Coastal Health Research Institute||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Chris Lockhart, BSc 604-875-4111 ext 68535 firstname.lastname@example.org|
|Contact: Kenneth Madden, MD 604-875-4931 email@example.com|
|Principal Investigator: Kenneth M Madden, MD MSc FRCPC|
|Principal Investigator:||Kenneth M Madden, MD||University of British Columbia|