Orthostatic HypotensionNCT01914146
Insulin Therapy and Falls Due to Orthostatic Hypotension
A study testing Insulin and No Insulin in people with Orthostatic Hypotension and Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Orthostatic Hypotension, Diabetes, Syncope
- What is being tested?
- Insulin and No Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 2 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
Read the 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
- Conditions
- Orthostatic Hypotension, Diabetes, Syncope
- Being tested
- Insulin, No Insulin
- Keywords
- Diabetes, Insulin, Orthostatic Hypotension, Falls, Syncope
- Medical subject headings
- Hypotension, Orthostatic, Diabetes Mellitus, Syncope, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinOther
Also called Lantus
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.
No InsulinOther
Study session will occur prior to initiation of insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Before Initiation of Insulin Therapy | Other | 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. Receives: Other: No Insulin |
| After Initiation of Insulin Therapy | Other | 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. Receives: Other: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Presence or absence of orthostatic hypotension
defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing
Measured: 1 day
Secondary outcomes (3)
1. The nadir of middle cerebral artery (MCA) velocity
lowest middle cerebral artery flow velocity determined by transcranial Doppler
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startApr 2015
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Why it stopped: Study was changed to Insulin, hypotension and sarcopenia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Madden, University of British Columbia
- Investigators
- Kenneth M Madden, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914146
- Sponsor's protocol ID
- H13-01375
- Status last verified
- Jan 2018
- First submitted
- 22 Jul 2013
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)
- ClinicalTrials.gov ID
- NCT01914146
- Acronym / sponsor ID
- H13-01375
- Conditions
- Orthostatic Hypotension, Diabetes, Syncope
- Keywords
- Diabetes, Insulin, Orthostatic Hypotension, Falls, Syncope
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was changed to Insulin, hypotension and sarcopenia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before Initiation of Insulin Therapy | Other | Other: No InsulinStudy 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. |
| After Initiation of Insulin Therapy | Other | Other: InsulinStudy 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinAlso: LantusInitiation 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 | After Initiation of Insulin Therapy |
| No InsulinStudy session will occur prior to initiation of insulin therapy. | Other | Before Initiation of Insulin Therapy |
Primary outcome
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
3 secondary outcomes
1. The nadir of middle cerebral artery (MCA) velocity
Time frame: 1 day
2. The presence or absence of a positive augmented tilt table test
Time frame: 1 day
3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Madden, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin and No Insulin in people with Orthostatic Hypotension and Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Presence or absence of orthostatic hypotension (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.