We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin Therapy and Falls Due to Orthostatic Hypotension

This study is currently recruiting participants.
Verified June 2017 by Kenneth Madden, University of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01914146
First Posted: August 1, 2013
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Madden, University of British Columbia
  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
Intervention Model: Single Group Assignment
Masking: None (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 Kenneth Madden, University of British Columbia:

Primary Outcome Measures:
  • 1. Presence or absence of orthostatic hypotension [ Time Frame: 1 day ]
    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 ]
    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 ]
    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 ]
    lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.


Estimated Enrollment: 45
Study Start Date: April 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914146


Contacts
Contact: Gale Tedder, RN, BSN 604-875-5115 gale.tedder@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 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

Responsible Party: Kenneth Madden, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01914146     History of Changes
Other Study ID Numbers: H13-01375
First Submitted: July 22, 2013
First Posted: August 1, 2013
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Syncope
Vascular Diseases
Cardiovascular Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs