T1 study in Newcastle

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T1 study in Newcastle

Postby artemis » Tue May 15, 2018 4:50 pm

The University of Newcastle, Australia is looking for #T1D volunteers for a study that aims to boost awareness of the importance of maintaining optimal brain health among those living with #diabetes. See the flyer below for further details or contact 02-4921 6408 or cnrc@newcastle.edu.au - See flyer at the below Facebook address.
https://www.facebook.com/diabetes.and.c ... jU&fref=nf

Volunteers must be aged between 30-80 and have been diagnosed before the age of 18.

Apparently the link doesn't work so here's the info from the UoN:
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PARTICIPANT INFORMATION STATEMENT
Dr Rachel Wong
Clinical Nutrition Research Centre
School of Biomedical Sciences & Pharmacy
University of Newcastle, Callaghan, NSW 2308
Tel: (02) 4921 6408; Email: Rachel.Wong@newcastle.edu.au
IS DYSFUNCTION OF BRAIN BLOOD VESSELS ASSOCIATED WITH
COGNITIVE IMPAIRMENT IN TYPE-1 DIABETES?
iNeuroT1D
INVESTIGATORS ROLE
Dr Rachel Wong Principal investigator & study coordinator
Associate Professor Ryu Takechi Co-Principal investigator
Emeritus Professor Peter Howe Co-investigator
Dr Matthew Albrecht Statistical Support
Mr Hamish Evans Research assistant
Ms Natasha Baker Research assistant
You are invited to participate in the research project identified above which is being conducted at The University
of Newcastle by, Dr Rachel Wong, NHMRC-ARC Dementia Research Fellow and Emeritus Professor Peter Howe
of the Clinical Nutrition Research Centre, in collaboration with Associate Professor Ryu Takechi and Dr Matthew
Albrecht of Curtin University.
WHO IS SUPPORTING THIS STUDY?
This project is funded by Hunter Medical Research Institute - Keith Tulloch Wines Project Grant
WHY IS THE RESEARCH BEING DONE?
Owing to better therapies, patients with type 1 diabetes are living longer and are now a unique population that
has been little studied. Differing from type 2 diabetes, the onset of type-1 diabetes is usually diagnosed at
childhood, but it is increasingly diagnosed in adulthood, requiring immediate insulin therapy. Regardless, both
types of diabetes result in blood vessel damage that can reduce blood flow to the brain. As a result, mental
function can decline earlier than expected.
However, those with type-1 diabetes are at higher risk of early decline in mental function than those with type2
diabetes. We believe that adults with type-1 diabetes have impaired blood vessel function in the brain even
before diagnosis, which in turn may have impacts on mental function throughout life.
This pilot project aims to characterise the extent to which poor vessel function in the brain is contributing to
poor mental function in adults with type-1 diabetes. Outcomes of this investigation will indicate whether type1
diabetes adults should have their mental function tested starting in their 40s and 50s as part of their on-going
diabetes management plan. This study will also provide scope for future studies to seek strategies to restore
blood vessel function and to prevent decline of mental function in young type-1 diabetics.
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WHAT ARE THE AIMS OF THIS STUDY?
We aim:
A. To evaluate blood vessel function in the brain and mental function in adults with a juvenile type-1
diabetes diagnosis and in healthy age-matched non-diabetic controls.
B. To explore the relationships between blood vessel function in the brain and in the whole body, mental
function, auditory function, cardiometabolic and inflammation biomarkers and blood-brain-barrier
integrity.
WHO CAN PARTICIPATE IN THIS STUDY?
We are seeking 30 adults who have been diagnosed with type-1 diabetes in childhood and 20 healthy controls.
In order to be suitable for the study, you must meet the following criteria:
For those with type-1 diabetes, you must
 be aged 30 - 80 years old
 Diagnosed before 18 years of age
 Not have advanced diabetes complications such as blindness or deafness
 Not have been hospitalised for severe glycemic events in the last three months
 be fluent in reading and writing in English
 understand the procedures involved and agree to participate in the study by giving full informed
consent.
To be considered in the control group, you must
 be aged 30 - 80 years old
 Not have a type-1 diabetes or type-2 diabetes diagnosis and HbA1c <6.5%
 Not be taking medication for hypertension and cholesterol
 be fluent in reading and writing in English
 understand the procedures involved and agree to participate in the study by giving full informed
consent.
You must NOT
 have no detectable transcranial Doppler (TCD) ultrasound signal in the middle cerebral artery on either
side (determined at your first visit)
 have liver or kidney disease
 have malignant cancer
 have an excessive alcohol intake (>15 drinks per week)
 be pregnant
 have neurological conditions including stroke, TIA, major depression, multiple sclerosis, Parkinson’s
disease or dementia or mild cognitive impairment.
 be unwilling to provide a blood sample.
WHAT IS INVOLVED?
Location: University of Newcastle, Clinical Nutrition Research Centre, Callaghan Campus, Medical
Sciences Building, Level 5, Room 514.
No. of visits to the clinic: 2
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Expression of interest: Should you wish to participate, you will be asked to read this Participant Information
Statement carefully and complete a Health, Diet & Lifestyle Questionnaire. The purpose of the Questionnaire is
to collect information about your lifestyle, medical history and details of any medications and/or dietary
supplements you are taking. It is important that you provide the study staff with as much information as possible
about your medical history, current health and lifestyle and medication use, as these may affect whether or not
you are able to participate in the study. We encourage you to speak to your GP about your potential involvement
in this study.
WHAT TO EXPECT?
Pre-Visit
Participants with type-1 diabetes will be sent a diary where you will be asked to log the frequency and
severity of hypoglycaemic episodes (subjective or having a blood glucose reading of <3.0mmol/L) in the
last two weeks before their first clinic visit. Additionally, you will also record your blood glucose levels
before breakfast and dinner or before bedtime and both long and short acting insulin doses consecutively
for two weeks in the diary. You will bring your completed diary with you to the first visit.
Visit 1: approx. 2.5 hours
This is a screening/baseline visit where your eligibility to participate will be assessed. Invited participants
are asked to abstain from food or stimulants for at least an hour (no caffeinated beverages for at least two
hours). Water is ok. To minimise hypoglycemic events during testing, participants are encouraged to have a
meal before the 1-hour fast. Those who are required to consume regular medication will do so prior to their
clinic visit.
Sequence of the visit will be as follows:
 Explanation of project by study investigators. You will have the opportunity to ask questions before
signing the consent form, which allows us to proceed with the following assessments:
 Body measurements for height, weight, waist circumference.
 Blood pressure and arterial compliance measurement.
o A blood pressure cuff will be placed on your upper arm. The blood pressure machine, similar
to the ones used at general practice, will inflate the cuff and the results of your blood pressure
will be determined automatically by the machine.
o You will sit down quietly for 10min before we measure your blood pressure and estimate how
flexible your blood vessels are.
 We will obtain a finger-prick glucose reading from type-1 diabetics to ensure that your blood glucose
levels are at least 6.5mmol/L before proceeding with the rest of the assessments. If glucose readings
fall below the cut-off, you will be given a carbohydrate snack (a snack packet of Tiny Teddies or a pack
of Le Snak biscuit and cheese) and asked to wait 20 min before we measure your glucose levels again.
A post-test finger-prick glucose reading will also be obtained as a safety measure to avoid
hypoglycaemia at the end of the mental testing. Fast acting carbohydrate snacks such as jelly beans or
a glucose tablet will be given if your value is less than 3.0mmol/L.
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Detecting blood flow signal in your brain during carbon dioxide stimulation:
o You will be fitted with a headpiece with ultrasound probes on either side of your forehead.
This non-invasive technique allows us to monitor blood flow in your brain. Participants will
be excluded if no measurable signal is obtained after 20 minutes.
o After we record your brain blood flow at rest, you will breathe a carbogen gas mixture (95%
oxygen and 5% carbon dioxide) for 3 minutes.
 The ultrasound head piece will record changes in your blood flow in the brain while you perform some
mental tests for approximately 90 minutes.
 At the conclusion of the visit, an appointment will be scheduled within seven days for visit 2.
Visit 2: approx. 1.5 hours
 You will return within seven days after having fasted for one hour, water is Ok.
 A small blood sample will be obtained from you to analysed for lipids, HbA1c and inflammatory
markers. This will be done at our campus pathology service.
 You will complete questionnaires that will ask you to report your current mood state, depressive
symptoms and diabetic self care (for participants with type-1 diabetes).
 You will then proceed to do a 10-min auditory function test and a manual dexterity test.
 Basic mental abilities will be assessed by a trained investigator
 Refreshments are provided at the conclusion of each visit. Jelly beans are readily available to
counteract any hypoglycaemic episodes during these assessments.
Participants are also able to complete all the assessments in a single visit if they choose. The anticipated duration
for such a visit is estimated as 4 h.
HONORARIUM
To assist with any costs incurred by participating, a sum of $20 will be given to those who complete the study. A
pro-rata payment of $10 will be given to those who complete the first visit.
WHAT CHOICES DO YOU HAVE?
Participation in this study is voluntary. Only participants who give their informed consent will be included in the
study. A decision not to participate will not disadvantage you.
If you decide to participate, you may withdraw from the study at any time without prejudice and without giving
a reason. You will have the option to withdraw the data that has been collected from you from being analysed.
However, data collected from you cannot be destroyed as we have to retain the data for the minimum period
of 20 years.
The study investigators may also stop your participation in the study, with or without your consent, if they feel
that it is in your best interest.
The study may also be stopped by the Ethics Committee to protect the rights and welfare of the study volunteers.
WHAT ARE THE RISKS AND BENEFITS OF PARTICIPATING?
All procedures will be carried out by qualified personnel and in accordance with Work Health & Safety guidelines.
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However, to help you make an informed decision, the risks and benefits associated with the various procedures
are set out as follows:
Risks:
Monitoring blood flow in the brain
Ultrasound is used to non-invasively measure blood flow in the brain. This is comparable to the ultrasound test
that is routinely performed on pregnant mothers and is harmless. The device sits snugly around your head just
above your eyebrows. When searching for a measureable signal, the headpiece will be tightened slightly and the
probes may be pressing slightly on your temples for the duration of the cognitive tests. Therefore, you may
experience a slight pressure. If the headpiece becomes uncomfortable, please notify the investigator who will
re-adjust the device to suit. To minimise exposure, the minimum settings will be used and ultrasound device
switched on only during recording.
Carbon dioxide stimulation
To test your blood vessel function in the brain, you will be asked to breathe in a gas mixture that consists of a
mixture of 5% of carbon dioxide and 95% oxygen for 3 mins each time. The gas is safe, colourless, odourless and
routinely use in medical procedure. This gas mixture is delivered via a mouth piece which will be sterilised
according to standard medical procedures before each use. There is a chance that you will experience some
dryness in your throat and mouth after breathing in the gas mixture. We will provide drinking water and sugar
free breath mints for our participants. There is also a chance of dizziness, headaches or convulsions after
breathing in carbogen gas. From our experience, no participants had suffered these symptoms after breathing
in carbogen gas. However, in the unlikely event of a severe adverse reaction to breathing in carbogen gas, we
will ceased all testing and inform campus security to call an ambulance and to render first aid. You will be advised
on these potential risks during the informed consent process.
Hypersensitivity to the disinfectant used for cleaning the mouthpiece – The procedures for disinfecting the
mouthpiece that is used for carbon dioxide stimulation are based on recommendations by the manufacturers
and have been approved by the University of Newcastle’s Health and Safety Committee. There may be a rare
chance of hypersensitivity to the high-level disinfectant that is used to clean the mouthpiece. Symptoms of
hypersensitivity may include swelling of the mouth, tongue and lips due to direct contact with the mouthpiece.
Volunteers who have known sensitivity to household chemicals will be required to inform the investigators prior
to the start of the carbon dioxide stimulation tests. The investigators will place a disposable cling-film over the
mouthpiece as a physical barrier between the mouthpiece and the volunteer to minimise the risk of
hypersensitivity reaction. If this is not possible, the volunteer will not be assessed on this test and may not be
eligible to continue the study.
Mental tests
Some participants may feel mildly distressed when completing the cognitive tests, as many of the tasks require
you to respond quickly or complete a number of tasks simultaneously. However, all volunteers should feel
assured that high performance levels on the tests are not expected. Should you become upset or distressed
before or any time during these tests, please inform the investigator.
Performing below one’s usual standard on mental tests is quite common, especially at the first visit to the study
site. This may be due to a variety of reasons such as unfamiliarity with the environment, misunderstanding of
test instructions, lack of sleep, tiredness, hunger, etc.
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Blood sample
A slight sting may be experienced during venepuncture. There is also a risk of minor bruising and infection with
open wounds. Participants will be asked to refrain from lifting heavy things for 24h and to keep the puncture
site dry and clean for 72h.
Severe hypoglycaemia
The study is designed to minimise hypoglycemic events during travel to and from the research site and during
cognitive testing by encouraging the participants to have a meal one hour before their scheduled visit. Various
carbohydrate rich snacks are also readily available to the participants. Finger prick glucose monitoring before
and after the visits will ensure that the participants do not suffer from a hypoglycemic episode when travelling
home from the research unit. Participants will be given some snacks to take with them. Should the participant
feel unwell during testing, the investigator will ring Health Services on campus who will render medical
assistance if necessary. Two investigators will always be on site during the clinic visits for this trial.
In addition, participants who record frequently low blood sugar levels in the diary will be advised to see their GP
as an adjustment to their insulin doses may be required.
Benefits
The blood tests are at no cost to you. Your individual blood test results may be shared with you and if necessary
you will be advised to consult with your usual GP for follow-up. At the conclusion of the study, participants will
be given a summary of findings of the group results in the form of a newsletter. However, no individual results
from the study will be released to participants.
HOW WILL YOUR PRIVACY BE PROTECTED?
Any information collected by the investigators which might identify you will be stored securely and only assessed
by the investigators unless you consent otherwise, except as required by law.
A numeric identification code will be assigned to volunteers who express interest in the study. This numeric
identification code will be used in all hard copies and electronic records of the data collected from each
volunteer. Only the investigators of this study will have access to these records for the duration of this
intervention. However, sharing of de-identified participant data with other investigator may be possible for
future ethically approved research.
The Health, Diet & Lifestyle questionnaire which you will return by post, or via email, will bear the numeric
identification code and responses entered into a spreadsheet that is protected by a password. If you do not
qualify for the study, your Health, Diet & Lifestyle Questionnaire will be destroyed immediately.
In the event of an adverse event or serious adverse event, we are required to report these findings to the Human
Research Ethics Committee. Your name, address and contact details will NOT be included the reports. However,
your characteristics such as age, gender, height, weight will be provided to the Human Research Ethics
Committee.
With your consent, we will contact your nominated GP regarding your participation in this study if necessary.
However, you are advised to discuss your study participation with your GP prior to study enrolment.
During statistical data analysis, the database will be stored in a password protected computer file on a computer
that is kept in a locked room. All data for the study will be retained on file and on site by the principal
investigators at the University of Newcastle, in a locked data storage site for a minimum of 20 years and
destroyed and electronic files deleted thereafter. Electronic files are secured by password only known to the
investigators of this study.
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HOW WILL THE INFORMATION COLLECTED BE USED?
Data collected in this study will be submitted for publication in scientific journals and presented at conferences.
A study report and progress report will also be submitted to the University’s Human Research Ethics Committee.
Individual volunteers will not be identified in any reports or publications arising from the study.
WHAT DO YOU NEED TO DO TO PARTICIPATE?
Please read this Information Statement and be sure you understand its contents before you consent to
participate. If there is anything you do not understand, or you have questions, please contact the Clinical
Nutrition Research Centre, Tel: 4921 6408 during working hours or email: cnrc@newcastle.edu.au.
If you would like to participate, please complete, sign and return the Health, Diet & Lifestyle Questionnaire. In
the questionnaire, you will have the option whether or not you would like to be contacted for future studies.
However, you are not obligated to participate in future studies and you may withdraw your consent to be
contacted anytime without prejudice. Please contact us if you did not receive the questionnaire. Upon receipt
of signed Health, Diet & Lifestyle questionnaire, an investigator will evaluate your suitability before inviting you
to come in for the screening/baseline visit.
At the screening visit, the study coordinator will explain the study and answer your questions pertaining to the
study. If you decide to participate in the study, you will then sign a Consent Form before proceeding with the
screening assessments.
FURTHER INFORMATION
Parking
Paid parking is available at the Callaghan Campus in areas marked ‘General Parking’ only. Failure to follow signs
may result in traffic infringement penalty which will be the responsibility of the volunteers. Limited visitor
parking spots (free) are also available. The investigators are unable to reserve a spot for you as they are available
on a first come first served basis. A Visitor Parking Permit will either be mailed to you following confirmation of
your clinic appointment or you can obtain the Parking Permit on site from the Study Coordinator when you
arrive. You must park only at the designated area marked ‘Health’.
For more information, please contact:
Dr Rachel Wong (4921 6408; rachel.wong@newcastle.edu.au),
Mr Hamish Evans and Ms Natasha Baker (4921 6691; cnrc@newcastle.edu.au)
Thank you for considering this invitation to participate in research undertaken at the University of Newcastle.
Dr Rachel Wong
Principal investigator, study coordinator
Associate Professor Ryu Takechi
Co-Principal investigator
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COMPLAINTS ABOUT THIS RESEARCH
This project has been approved by the University’s Human Research Ethics Committee, Approval No. H-2018-
0038.
Should you have concerns about your rights as a volunteer in this study, or you have a complaint about the
manner in which the study is conducted it may be given to the investigator, or, if an independent person is
preferred to the Human Research Ethics Office, Research & Innovation Services, The University of Newcastle,
University Drive, Callaghan NSW 2308, Australia, Telephone (02) 4931 6333, email: HumanEthics@newcastle.edu.au
Jane
Infundo ergo sum.
artemis
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