Insulin Therapy and Falls Due to Orthostatic Hypotension

Not Applicable

Withdrawn

• Conditions: Diabetes; Syncope; Orthostatic Hypotension
• Interventions: Other: Insulin; Other: No Insulin

• Registration Number: NCT01914146
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Study Start: 2015-04
• Status Verified: 2018-01
• Primary Completion: 2018-01-02
• Study Completion: 2018-01-02
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All subjects must be 65 years of age or older
• All must have been diagnosed with Type 2 diabetes for at least 5 years
• All subjects must be insulin-naïve on recruitment
• All subjects must be eligible to start insulin therapy (long or intermediate acting) as determined by their diabetologist

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Exclusion Criteria

• Anemia, as determined by serum hematocrit
• Abnormal liver function tests
• Elevated creatinine
• Smoker
• Musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
After Initiation of Insulin Therapy	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.
Before Initiation of Insulin Therapy	No Insulin	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.

Primary Outcome Measures

Name	Time	Method
1. Presence or absence of orthostatic hypotension	1 day	defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing

Secondary Outcome Measures

Name	Time	Method
3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.	1 day	lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.
1. The nadir of middle cerebral artery (MCA) velocity	1 day	lowest middle cerebral artery flow velocity determined by transcranial Doppler
2. The presence or absence of a positive augmented tilt table test	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.

Trial Locations

Locations (1)

Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue; 🇨🇦 Vancouver, British Columbia, Canada