Insulin Therapy and Falls Due to Orthostatic Hypotension

Sponsor

University of British Columbia (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01914146

Collaborator

(none)

Enrollment

Location

Arms

33.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthostatic Hypotension Diabetes Syncope	Other: Insulin Other: No Insulin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jan 2, 2018

Actual Study Completion Date :

Jan 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.	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. Other Names: Lantus

Arm

Intervention/Treatment

Other: 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.

Other: 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.

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.

Other Names:

Lantus

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	V5Z 1M9