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Clinical Trials
Click on one
of the links below to view information on individual trials, or click
on the star to see an overview of all trials currently being conducted
by this Centre.
This area was last updated on May 29, 2009
Ongoing Trials
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Completed Trials
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INIT
II (Intranasal Insulin) Trial
Type 1 diabetes
is a condition in which the immune system reacts against the insulin-producing
beta cells in the pancreas, eventually destroying the beta cells and
causing a lack of insulin. Without the hormone insulin, the cells of
the body are unable to use glucose and the level of glucose in the blood
increases and causes symptoms of diabetes.
The aim of the INIT II trial is to determine if exposure of the immune
system in the mucus membranes to insulin, by treatment with intranasal
insulin, will stop the immune reaction and further loss of beta cells. This could prevent diabetes and the need for insulin injections.
The intranasal insulin acts only on the mucus membranes and is not absorbed
into the body. Insulin given this way does not affect blood glucose
and will not cause hypoglycaemia (“hypos”).
The INIT II trial is now recruiting in Australia and New Zealand! Visit the INIT II website at www.stopdiabetes.com.au/
Read more about INIT II
TrialNet
Natural History Study
Type
1 diabetes is a life-long condition that can affect both children and
adults. It occurs when the body attacks and destroys the cells in the
pancreas that make insulin. The body needs insulin, a hormone, to turn
food into energy. The goal of this study is to increase our understanding
of how type 1 diabetes develops over time. Better understanding may help
to prevent diabetes or develop a cure.
Read more about the TrialNet Natural History Study
Lap-Band surgery versus lifestyle in type 2 diabetes
We know that diabetes improves dramatically when obese people lose around 20 kilos. Afterwards, most have normal blood sugar levels despite stopping medication. A recent study in people who were obese showed huge improvements for those with diabetes who had a lap band. We are trying to find out if lap banding is better than lifestyle approaches for people newly diagnosed with type 2 diabetes who are overweight.
Read more about Lap-Band surgery versus lifestyle in type 2 diabetes
Vitamin D and Autoimmune Adult-Onset Diabetes
Vitamin D is a steroid hormone with anti-inflammatory properties. People with lower levels of vitamin D may be more susceptible to inflammatory diseases such as type 1 diabetes. The aim of this study is to determine whether vitamin D repletion will slow the progression of adult-onset autoimmune diabetes, possibly obviating the need for insulin injections.
*** This study is no longer recruiting ***
Read more about the Vitamin D study
Type
1 Diabetes Genetics Consortium
The Type 1 Diabetes Genetics Consortium is a group of diabetes researchers
from around the world who have come together to collect samples and information
from families with Type 1 diabetes.
We are trying
to discover how differences in the genes that we inherit from our parents
contribute to the risk for development of Type 1 diabetes. Genes are the
“blue prints” in our bodies that we get from our parents at
birth. Genes decide our characteristics like the color of our hair, our
eyes and the shape of our bodies. Some genes are also involved in whether
you have diabetes or not. If we find out more about these genes, we may
be able to prevent diabetes in the future.
*** This study is no longer recruiting ***
Read more about the Type 1 Diabetes Genetics Consortium
Completed Trials
INIT
III (LADA) Trial
Up
to one in ten adults with presumed type 2 diabetes have features of
both forms of diabetes, ie 'type 1.5 diabetes', and they are at higher
risk of rapidly progressing to insulin injection treatment, often
within several years after diagnosis. Adults with type 1.5 diabetes
have insulin resistance, but are also found to have antibodies responsible
for beta-cell destruction. The presence of these antibodies gives
type 1.5 diabetes its other name, 'latent autoimmune diabetes in adults'
(LADA).
The
INIT III trial is a clinical trial involving an immune therapy in
the form of insulin given as a nasal spray to determine whether it
can delay or prevent the need for insulin injections.
Read more about the INIT III Trial
TrialNet MMTT-GST Research Study
When we conduct clinical research in people with type 1 diabetes, it is important for us to know how much insulin is still being produced by the pancreas. Currently, two tests, a Mixed Meal Tolerance Test (MMTT) and a Glucagon Stimulation Test (GST) have been used to measure insulin production. The aim of this study is to compare these two tests to find out which is a better measure of insulin secretion, and which test people tolerate better.
This test will help us develop a standardised way to test for insulin production in pre-clinical and clinical type 1 diabetes. A standardised test of this kind will be invaluable both for planning intervention and prevention studies in type 1 diabetes and for measureing their outcome.
Read more about the MMTT-GST Research Study
Australian BabyDiab Study
As you may
know, type 1 diabetes (also known as insulin-dependent or juvenile diabetes)
is known to run in families. If a child's mother, father, brother or
sister have insulin dependent diabetes, his or her risk of developing
diabetes in increased. In studies of families in which one or more members
have diabetes we have found it is possible to use a blood test for antibodies
to the pancreas (called islet autoantibodies) to identify other family
members at risk for diabetes. There is evidence that these antibodies
to the pancreas develop within the first six years of life.
This study
will identify those at increased risk for type 1 diabetes and observe
them over time. It will also aid in the recruitment and assessment of
those who might qualify for future diabetes prevention trials. Eligible
participants would be offered participation in prevention trials as
these become available.
Read more about the Australian BabyDiab Study
INIT I Trial
The ability to use self-antigens
as tools to induce protective immunity, free from the side-effects of
conventional non-specific immunosuppressive agents, is the 'Holy Grail'
of autoimmune disease therapy. Administration via 'tolerogenic' mucosal
routes in animal models has provided proof-of-concept for such antigen-specific
therapy. For example, we have shown that regulatory T cells that prevent
diabetes can be induced by administering insulin to the naso-respiratory
tract of diabetes-prone mice.
On this background, we conducted a trial of intranasal insulin in 38 humans
(median age 10.8 years) at risk for type 1 diabetes to determine the effect
of intranasal insulin on immune and metabolic markers and to ensure that
this potentially immunoprotective strategy was safe. The intranasal insulin
trial (INIT) was randomized, placebo-controlled and double-masked, with
a crossover at six months. A separate cohort of 13 subjects (median age
13.0 years), was followed to symptomatic diabetes over 1.0-7.7 years up
to the time the trial commenced.
Read more about the INIT I Trial
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