Insulin Therapy and Falls Due to Orthostatic Hypotension
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|ClinicalTrials.gov Identifier: NCT01914146|
Recruitment Status : Withdrawn (Study was changed to Insulin, hypotension and sarcopenia)
First Posted : August 1, 2013
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Orthostatic Hypotension Diabetes Syncope||Other: Insulin Other: No Insulin||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2, 2018|
|Actual Study Completion Date :||January 2, 2018|
Before Initiation of Insulin Therapy
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 occur prior to initiation of insulin therapy.
After Initiation of Insulin Therapy
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.
Other Name: Lantus
- 1. Presence or absence of orthostatic hypotension [ Time Frame: 1 day ]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 ]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 ]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 ]lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914146
|Canada, British Columbia|
|Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Kenneth M Madden, MD||University of British Columbia|