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Trial registered on ANZCTR


Registration number
ACTRN12616000431426
Ethics application status
Approved
Date submitted
24/03/2016
Date registered
5/04/2016
Date last updated
5/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the link between blood glucose levels and neurocardiogenic syncope in adults who experience fainting episodes.
Scientific title
Evaluation of the link between blood glucose levels and neurocardiogenic syncope in adults undergoing tilt table testing for syncopal events.
Secondary ID [1] 288903 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocardiogenic syncope 298125 0
Hypoglycemia 298126 0
Condition category
Condition code
Cardiovascular 298294 298294 0 0
Other cardiovascular diseases
Metabolic and Endocrine 298295 298295 0 0
Metabolic disorders
Neurological 298375 298375 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The normal procedure for a heads-up tilt test is were the test is divided into two sections, Before the test commences the patient's blood pressure and heart rate are assessed. A small needle (like a blood test) will be placed in the arm (IV cannula) which medication will be given in the second part of the test.

The patient lies flat on the tilt bed that has a footplate at the end to stand on when the bed has been tilted so that they are standing upright. Small straps are placed around the body, like seat belts that stabilize the patient in case they become dizzy or faint.

After 10 minutes in this in the upright standing position, or sooner if they become dizzy or feel faint, the bed will be returned to the normal position so that they are lying flat.
The heart rate and blood pressure will be taken frequently.

If no blackouts or dizziness occurs, then the second part of the test begins.

The tilt test is repeated with the addition of a medication (Isoprenaline) given via the small needle (IV cannula) in the arm The Isoprenaline stimulates the heart rate (making the heart beat stronger and faster), it makes you feel like you have gone for a brisk walk or run, similar to how you feel when you exercise.

Similar to the first part of the tilt table test the second part of the test continues for 10 minutes or until the patient becomes dizzy or feels faint.

As part of this project we will be checking the patient's venous blood glucose level at the following time points:
-Before the test begins (Baseline)
-After the first part of the tilt (after 10minutes)
-2 minutes after the Isoprenaline infusion part of the test has commenced
-After the end of the Isoprenaline phase of the test (End of test)

The only change from a standard tilt table test is the blood sample collection and testing for blood glucose levels.



Intervention code [1] 294298 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297775 0
The evaluate the change in circulating blood glucose levels in response to syncope.
Timepoint [1] 297775 0
Ee will be checking the patient's venous blood glucose level at the following time points:
-Before the test begins (Baseline)
-After the first part of the tilt (after 10minutes)
-2 minutes after the Isoprenaline infusion part of the test has commenced
-After the end of the Isoprenaline phase of the test (End of test)
Secondary outcome [1] 322180 0
To analyse the blood glucose levels of participants in Tilt Table Testing who have a positive result on the test (ie hypotension) and compare the blood glucose levels to those who have a negative result, to see if any change in blood glucose levels can be related to the occurrence of hypotension itself rather than other aspects of the test.
Timepoint [1] 322180 0
We will be checking the patient's venous blood glucose level at the following time points:
-Before the test begins (Baseline)
-After the first part of the tilt (after 10minutes)
-2 minutes after the Isoprenaline infusion part of the test has commenced
-After the end of the Isoprenaline phase of the test (End of test)

Eligibility
Key inclusion criteria
Referred for Tilt Table Testing for syncopal events.
Participants will be over 18 years of age
Willing and able to sign an informed consent form
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are diabetic,
Those that are taking medication that interferes with blood glucose levels.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The serial blood glucose measurements from the syncopal patients will be compared to those in the control group using analysis of variance. Clinically significant hypoglycemia will be defined as a blood sugar <3.0 and the proportion of patients with symptomatic hypoglycemia will be determined in both the symptomatic and control groups. If a significant proportion of patients do show evidence of clinically significant hypoglycemia then an attempt will be made to correlate the occurrence of clinically significant hypoglycemia with gender and age.
In the past patient's frequently reported that they could stop syncopal events by taking sugar. From this observation we decided that 50 patients would be enough to show a difference in the glucose levels at different time points. No formal power calculation was performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5485 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 12968 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 293201 0
Hospital
Name [1] 293201 0
Cardiology Department - Box Hill Hospital
Address [1] 293201 0
Box Hill Hospital
Cardiology Department
8 Arnold St
Box Hill, Vic, 3128
Country [1] 293201 0
Australia
Primary sponsor type
Individual
Name
Dr Angas Hamer
Address
Box Hill Hospital
Cardiology Department
8 Arnold St
Box Hill, Vic, 3128
Country
Australia
Secondary sponsor category [1] 292059 0
None
Name [1] 292059 0
None
Address [1] 292059 0
None
Country [1] 292059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294686 0
Eastern Health Research and Ethics
Ethics committee address [1] 294686 0
Eastern Health
5 Arnold St
Box Hill, Vic, 3128
Ethics committee country [1] 294686 0
Australia
Date submitted for ethics approval [1] 294686 0
23/04/2009
Approval date [1] 294686 0
09/06/2009
Ethics approval number [1] 294686 0
E92/0809

Summary
Brief summary
Given the hypothesis that reactive hypoglycemia may occur during hypotensive (neurocardiogenic) syncope we wish to study blood glucose levels in patients who may have a hypotensive syncopal event. Establishing a link between reactive hypoglycemia and neurocardiogenic hypotensive syncope could be beneficial to these patients as it may lead to new strategies to help these patients manage their events.

This study differs from previous studies by testing the blood glucose levels in a large number of patients referred for an investigation of neurocardiogenic before and during syncope induced by a Tilt Table Test, using referred patients who do not have syncope induced during the test as a control group.

Trial website
None
Trial related presentations / publications
None
Public notes
This study is now completed, and awaiting publication

Contacts
Principal investigator
Name 64662 0
Dr Angas Hamer
Address 64662 0
Box Hill Hospital
Cardiology Department
Level 2, Building B
Nelson Rd
Box Hill, Vic 3128
Country 64662 0
Australia
Phone 64662 0
+61 3 9895 4855
Fax 64662 0
+61 3 9895 4834
Email 64662 0
aham8655@bigpond.net.au
Contact person for public queries
Name 64663 0
Dr Louise Roberts
Address 64663 0
Box Hill Hospital
Cardiology Research
Level 2, 5 Arnold St
Box Hill, Vic 3128
Country 64663 0
Australia
Phone 64663 0
+61 3 9095 2441
Fax 64663 0
+61 3 9895 4834
Email 64663 0
Louise.roberts@easternhealth.org.au
Contact person for scientific queries
Name 64664 0
Dr Louise Roberts
Address 64664 0
Box Hill Hospital
Cardiology Research
Level 2, 5 Arnold St
Box Hill, Vic 3128
Country 64664 0
Australia
Phone 64664 0
+61 3 9095 2441
Fax 64664 0
+61 3 9895 4834
Email 64664 0
Louise.roberts@easternhealth.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary