Insulin Therapy and Falls Due to Orthostatic Hypotension

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes; Syncope; Orthostatic Hypotension
• Intervention / Treatment: Other: No Insulin; Other: Insulin

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. The nadir of middle cerebral artery (MCA) velocity	lowest middle cerebral artery flow velocity determined by transcranial Doppler	1 day
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.	1 day
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.	1 day

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Kenneth M Madden, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 2, 2018
• Study Completion (Actual): January 2, 2018

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Insulin; Syncope; Falls; Orthostatic Hypotension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Syncope; Hypotension, Orthostatic; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: H13-01375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO