Insulin Therapy and Falls Due to Orthostatic Hypotension

This study is not yet open for participant recruitment.
Verified January 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: January 13, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Orthostatic Hypotension
Diabetes
Syncope
Drug: Insulin ( Lantus)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 45
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Start of Insulin Therapy
Standard Insulin Therapy. Measurements will be taken before and 2 weeks after the initiation of the Therapy.
Drug: Insulin ( Lantus)
Standard Insulin Therapy will be prescribed by the diabetologist. Testing will be done pre and post start of the insulin therapy.
Other Name: Lantus

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
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914146

Locations
Canada, British Columbia
UBC VITALiTY Research, Dept. of Medicine, Vancouver Coastal Health Research Institute Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Chris Lockhart, BSc    604-875-4111 ext 68535    chris.lockhart@vch.ca   
Contact: Kenneth Madden, MD    604-875-4931    kmmadden@mail.ubc.ca   
Principal Investigator: Kenneth M Madden, MD MSc FRCPC         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kenneth M Madden, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01914146     History of Changes
Other Study ID Numbers: H13-01375
Study First Received: July 22, 2013
Last Updated: January 13, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Diabetes
Insulin
Orthostatic Hypotension
Falls
Syncope

Additional relevant MeSH terms:
Diabetes Mellitus
Hypotension
Hypotension, Orthostatic
Syncope
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014