Insulin Therapy and Falls Due to Orthostatic Hypotension

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01914146
First received: July 22, 2013
Last updated: July 16, 2014
Last verified: July 2014

July 22, 2013
July 16, 2014
July 2014
June 2015   (final data collection date for primary outcome measure)
1. Presence or absence of orthostatic hypotension [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
Same as current
Complete list of historical versions of study NCT01914146 on ClinicalTrials.gov Archive Site
  • 1. The nadir of middle cerebral artery (MCA) velocity [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.
Same as current
Not Provided
Not Provided
 
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.

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
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Orthostatic Hypotension
  • Diabetes
  • Syncope
  • 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 Name: Lantus
  • Other: No Insulin
    Study session will occur prior to initiation of insulin therapy.
  • 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.
    Intervention: Other: No Insulin
  • 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.
    Intervention: Other: Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Gale Tedder, RN, BSN 604-875-5115 gale.tedder@vch.ca
Contact: Chris Lockhart, BSc 604-875-4111 ext 68535 chris.lockhart@vch.ca
Canada
 
NCT01914146
H13-01375
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Kenneth M Madden, MD University of British Columbia
University of British Columbia
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP