Rationale for the TRIGR
The rationale 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 milk proteins into smaller components. Decreased
rates of type 1 diabetes development were found in animals
weaned to hydrolyzed proteins instead of intact foreign
proteins. Some evidence is now available suggesting
that a similar relationship may exist in humans, but
further research is needed.
A randomized controlled trial - the standard type of
research study to determine whether a medical treatment
is effective in humans - is the next step to find out
whether this work will lead to protection against type
1 diabetes. Such a trial has been developed and tested
by an international team of physicians and scientists first
led by Prof. Hans Åkerblom and currently by Prof. Mikael Knip in Helsinki, Finland.
These years of development and study set the stage for
the multinational TRIGR trial, now underway on three