Clinical Trials Supported by JDRF in Australia
TRIGR Trial
Is there a connection
with an infant's nutritional intake and the onset of type 1 diabetes?
The TRIGR trial
is a study on the nutritional prevention of type 1 diabetes. TRIGR
stands for "Trial to Reduce the Incidence of Type 1 Diabetes
in the Genetically at Risk".
TRIGR is a global
research study to find out if there is a connection between diet
in infancy and the development of type 1 diabetes - and whether
modifying the infant's diet can prevent or reduce the incidence
of diabetes in children shown to be genetically at risk.
The TRIGR trial
is being conducted at over 40 centres across the U.S., Canada, Europe
and Australia. In Australia, the trial is being co-ordinated at
The Children's Hospital at Westmead, NSW.
Families in
which the expected newborn's mother, father or full-sibling has
type 1 diabetes are invited to participate.
Researchers
first determine whether the infant is at high risk of developing
diabetes, through test using cord blood (which is collected at birth).
Only infants at high risk continue in the study. The follow-up period
for the study is 10 years.
Inquiries should
be directed to:
Glenda Fraser
Nurse Co-ordinator
Tel: 02 9845 3201
Fax: 02 9845 3170
Mob: 0408 162 559
Email: glendaf3@chw.edu.au
Islet Transplantation
The federal
government is joining with the Juvenile Diabetes Research Foundation
to fund an Australian Islet Transplantation Global Centre of Excellence
as part of an established international network of islet transplantation
clinical and research programs.
The world-class
research centre aims to take islet cell transplantation from an
experimental procedure to a genuine clinical option for all Australians
with type 1 diabetes. JDRF expects the centre to be operating by
the end of 2005.
In the meantime,
the only islet transplantation underway in Australia is at the National
Pancreas Transplant Unit at Westmead Hospital. While no islet transplant
procedures are planned in the near future, due to funding shortages,
people have shown widespread interest in being added to the waiting
list.
If you are interested
in pursuing this option:
- You must
speak with your endocrinologist about islet transplantation and
whether you are a potential candidate for this procedure.
- If your
endocrinologist feels you fulfil the current criteria, they will
need to refer you to Professor Phillip O'Connell, Director of
the National Pancreas Transplant Unit, Westmead Hospital (Darcy
Rd - Cnr Hawksbury Rd, Westmead NSW 2145)
Preventing Type 1 Diabetes - Nasal Insulin
Trial
In 2004, Prof
Len Harrison's research team at the Walter & Eliza Hall Institute
of Medical Research in Melbourne announced that they have developed
a potential vaccine for type 1 diabetes.
Results of a
successful phase II human clinical trial have shown that a nasal
insulin spray can protect children at high risk of developing type
1 diabetes, preventing them from developing the potentially fatal
disease for at least five years.
A team lead
by Prof Len Harrison conducted the phase II trial at The Royal Melbourne
Hospital in children at high risk of developing type 1 diabetes.
Of the 38 children in the trial, 12 who started with very little
or no insulin-producing function went on to develop diabetes within
one to two years. However, of the other 26, all of whom began the
trial with some of their own insulin-producing function, none developed
diabetes after three years.
This clinical
human trial followed more than 10 years' successful work in mouse
models with type 1 diabetes.
The vaccine
teaches the immune system to protect the insulin-producing cells
in the pancreas, rather than attack them and trigger the development
of type 1 diabetes.
Prof Harrison
and his team are in final preparations for a third, much larger
trial in a group of at-risk children and young adults. The trial
will use several doses of nasal insulin to determine the best outcome.
Between 12,000
and 20,000 people at risk of type 1 diabetes will be screened to
find at least 200 with antibodies present, to participate in the
five-year trial.
If you are interested
in finding out more about this world-leading research and potentially
participating in the trial, please visit www.diabetestrials.org
or contact:
Fiona Williams
Clinical Trials Manager
The Walter and Eliza Hall Institute of Medical Research
Tel: 03
93452460
Fax: 03
93470852
Email: fwilliams@wehi.edu.au
TRIALNET
The Type 1 Diabetes
TrialNet Study Group is an international group of investigators
in the United States, Canada, Europe, and Australia/New Zealand.
They are dedicated to testing new approaches to prevent and treat
type 1 diabetes.
TrialNet has
two major goals:
- To identify
relatives of people with type 1 diabetes who may be at risk for
developing diabetes for enrollment in both observation and treatment
trials
- To identify
people who have been diagnosed with type 1 within the past three
months, to see if interventions (treatments) may preserve some
of their ability to make insulin
TrialNet is
funded by the USA National Institutes of Health, the American Diabetes
Association and the Juvenile Diabetes Research Foundation.
Relatives of
people with type 1 diabetes have about a 3 to 4 percent chance of
testing positive for anti-bodies associated with diabetes. A positive
antibody test is an early indication that damage to insulin-secreting
cells may have begun - the first step in the onset of type 1 diabetes.
TrialNet will
identify adults and children at risk for developing diabetes by
testing for the presence of these antibodies in the blood. If this
test is positive, additional testing will be offered to determine
the likelihood that a person may develop diabetes. Those at risk
for developing the disease may be able to join the TRIALNET clinical
trial.
This study will
enable researchers to learn more about risk factors associated with
the development of type 1 diabetes. It will offer participants additional
testing and provide close monitoring every six months to monitor
for the early detection of type 1 diabetes. Early detection may
improve blood glucose control and reduce the chance of developing
diabetes-related complications.
If you are interested
in finding out more about this world-leading research and potentially
participating in the trial, please visit www.diabetestrials.org
or contact:
Fiona Williams
Clinical Trials Manager
The Walter and Eliza Hall Institute of Medical Research
Tel: 03
93452460
Fax: 03
93470852
Email: fwilliams@wehi.edu.au
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