Type 1 diabetes develops when the body can no longer produce sufficient
insulin, the hormone needed for cells to convert glucose to energy.
It is called an autoimmune disease, because the body's own immune
system destroys the insulin-producing cells in the pancreas. Untreated,
type 1 diabetes is soon fatal. People with type 1 diabetes need
to take insulin artificially, either through injection or
with a device known as an insulin pump. Additional information
on this condition is available from the Juvenile Diabetes
Research Federation website
The cause of type 1 diabetes has been investigated for several
decades. Strong evidence suggests that environmental factors increase
the risk of diabetes in people who are genetically susceptible.
If these environmental factors could be identified and eliminated,
it should be possible to decrease the number of children who
develop type 1 diabetes.
The history for TRIGR began with observational studies
that showed that breastfeeding was associated with somewhat
lower rates of children developing type 1 diabetes. These
studies first appeared in the mid-1980's. At virtually
the same time, basic research began focusing on the role of cow's
milk proteins in diabetes in animals. The reason to focus
on cow's milk was motivated by the fact that cow's
milk based infant formula is the foreign intact food protein
most commonly encountered first by babies. Recently, studies have
focused on hydrolyzed formulas—those in which a chemical
reaction was used to break down the proteins into very small protein
components, too small to be recognized and targeted by the immune system.
Decreased rates of type 1 diabetes development were found in all animal
studies that tested weaning to hydrolyzed proteins instead of intact
foreign proteins. Some evidence is now available suggesting that a
similar relationship may exist in humans. It appears that the immune
system in young infants with genetic diabetes risk is less mature
and unable to normally handle intact foreign food proteins.
This sets up a chain reaction that can lead to autoimmune
destruction of insulin-producing cells.
A randomized controlled trial—the standard type of research
study to determine whether a medical treatment is effective
in humans—was the next step to find out whether this work
will lead to protection against type 1 diabetes. These years of
development and study set the stage for the multinational TRIGR trial,
now well underway on three continents with 2160 eligible infants
randomized to test or control formulas when mothers decide to wean
from exclusive breastfeeding. The participants will be monitored up
to the age of 10 years for the appearance of diabetes-predictive
autoantibodies and clinical type 1 diabetes.
The TRIGR study was designed not to interfere with infant feeding
practices, except to emphasize and encourage breastfeeding.
All mothers who participate in TRIGR are counseled and supported to
exclusively breastfeed their babies for the first six months of life
in accordance with the World Health Organization 2001 recommendation
based on the benefits of breastfeeding for this time period
However, one problem often encountered by mothers who have
type 1 diabetes themselves is that exclusive breastfeeding
cannot be sustained for medical reasons.
The TRIGR trial will determine whether delayed exposure to
intact food proteins will reduce the chances of developing
type 1 diabetes later in life. All babies in the study received
the recommendation to breastfeed for at least the first six
months of life. If a mother was unable to exclusively breastfeed
before the baby was 8 months of age, her child was randomly
assigned to one of two groups. One group of these babies received
a trial formula based on extensively hydrolyzed protein; the other
group received another trial formula containing a smaller amount of
hydrolyzed protein. In the hydrolyzed formula, the big protein molecules
have been split into very small fragments to provide a source
of nutritional amino acids, but the fragments are likely too
small to stimulate the immune system.
All TRIGR families have access and continued support
by a local team of pediatricians, nurses, and dieticians. Perhaps
because of this support and the information provided, more
mothers were able to exclusively breastfeed for significantly
longer periods than expected from previous research studies,
including the TRIGR pilot studies that were conducted mainly in
Finland. These pilot studies developed and tested the complex
infrastructure required for a very large disease prevention
trial such as TRIGR. For this performance reason, the TRIGR trial
will also be able to analyze whether exclusive breastfeeding
per se can reduce the risk of the children to develop
type 1 diabetes.
The last child was randomized to the study in February 2007. All
children will be observed until the age of 10 years, so we expect to
have the final results of the study available in year 2017. An
independent, international board continuously monitors the trial's
performance, and this board also determines if significant results
appear with respect to disease or signs of impending disease. This
is the largest and perhaps most ambitious primary type 1 diabetes
prevention trial to date.
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