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
  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
Orthostatic Hypotension
Diabetes
Syncope
Other: Insulin
Other: No Insulin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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: July 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914146

Contacts
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

Locations
Canada, British Columbia
Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Gale Tedder, RN, BSN    604-875-5115    gale.tedder@vch.ca   
Contact: Kenneth Madden, MD    604-875-4931    kmmadden@mail.ubc.ca   
Principal Investigator: Kenneth M Madden, MD MSc FRCPC         
Sub-Investigator: Graydon Meneilly, MD, FRCPC         
Sub-Investigator: Nicole Stewart, MD         
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: July 16, 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
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014