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Insulin Therapy and Falls Due to Orthostatic Hypotension

Primary Purpose

Orthostatic Hypotension, Diabetes, Syncope

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Insulin
No Insulin
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Orthostatic Hypotension focused on measuring Diabetes, Insulin, Orthostatic Hypotension, Falls, Syncope

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Before Initiation of Insulin Therapy

After Initiation of Insulin Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

1. Presence or absence of orthostatic hypotension
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
lowest middle cerebral artery flow velocity determined by transcranial Doppler
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.
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.

Full Information

First Posted
July 22, 2013
Last Updated
January 8, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01914146
Brief Title
Insulin Therapy and Falls Due to Orthostatic Hypotension
Official Title
Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study was changed to Insulin, hypotension and sarcopenia
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2, 2018 (Actual)
Study Completion Date
January 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension, Diabetes, Syncope
Keywords
Diabetes, Insulin, Orthostatic Hypotension, Falls, Syncope

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Before Initiation of Insulin Therapy
Arm Type
Other
Arm Description
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.
Arm Title
After Initiation of Insulin Therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Insulin
Other Intervention Name(s)
Lantus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Insulin
Intervention Description
Study session will occur prior to initiation of insulin therapy.
Primary Outcome Measure Information:
Title
1. Presence or absence of orthostatic hypotension
Description
defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
Time Frame
1 day
Secondary Outcome Measure Information:
Title
1. The nadir of middle cerebral artery (MCA) velocity
Description
lowest middle cerebral artery flow velocity determined by transcranial Doppler
Time Frame
1 day
Title
2. The presence or absence of a positive augmented tilt table test
Description
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
Title
3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.
Description
lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Madden, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Insulin Therapy and Falls Due to Orthostatic Hypotension

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