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June 10, 2002: Canadian Institutes of Health
Research Press Release
National Institutes of Health:
National Institute of Child Health and Human Development
For Immediate Release June 10, 2002
Contact: Robert Bock or Susan Marsiglia (301) 496-5133
Study To Assess Relation of Infant Formula
to Risk of Developing
Type 1 Diabetes
A large, multinational study will be undertaken to
assess the relationship of infant formula consumption
to the likelihood of developing insulin-dependent (type
1) diabetes in certain genetically at-risk infants.
The study will be jointly funded by the National Institute
of Child Health and Human Development (NICHD), the Canadian
Institutes of Health Research (CIHR), the Juvenile Diabetes
Research Foundation International (JDRF), the European
Foundation for the Study of Diabetes (EFSD), Novo Nordisk,
and the Netherlands Diabetes Foundation (NDF) and the
European Union. The trial is called TRIGR, which stands
for the Trial to Reduce Insulin-Dependent Diabetes Mellitus
in the genetically at risk. Type 1 diabetes develops
when the body can no longer produce adequate insulin,
which is needed for cells to convert glucose to energy.
People with type 1 diabetes need to take insulin artificially,
either through injection or with a device known as an
insulin pump. Untreated, type 1 diabetes is soon fatal.
Additional information on this disorder is available
from the National Institute of Diabetes and Digestive
and Kidney Diseases at http://www.niddk.nih.gov/health/diabetes/pubs/type1-2/what.htm.
The study will compare the rates of development of
type 1 diabetes in infants given hydrolyzed cow's milk
based formula versus a standard cow's milk-based formula.
The hydrolyzed formula to be studied is called Nutramigen
® and is one of the formulas which can be given
to infants who may be allergic to casein, one of the
principal proteins in cow's milk. "Hydrolyzed"
refers to the process of breaking down the protein casein
into smaller molecules. Some scientists have suggested
that exposure to casein or other proteins in cow's milk
formula or soy based-formula may trigger the immune
system attack that destroys insulin-making cells. The
Mead Johnson Company will donate all of the infant formula
to be used in the study.
Animal studies have shown that hydrolyzed cow's milk-based
formulas decrease the incidence of type 1 diabetes in
strains of rats and mice that are genetically likely
to develop the condition. Studies of whether early introduction
of formula increases the likelihood of development of
type 1 diabetes in human beings have produced contradictory
The study seeks to enroll 2370 infants who have a
parent or sibling with diabetes and who have inherited
certain genes that predispose them to type 1 diabetes.
The 5 year study will receive $6 million in funding
from the National Institute of Child Health and Human
Development (NICHD) and $3 million in funds appropriated
by Congress for research on type 1 diabetes. The JDRF
will contribute $3 million and a partnership consisting
of the EFSD, the health care firm Novo Nordisk, and
the JDRF jointly will contribute up to $1.2 million.
The CIHR will contribute about $5 million and the NDF
about $280,000. This major clinical study will recruit
infants at sites in 14 countries: the U.S. and Puerto
Rico, Canada, Australia, Finland, Sweden, Germany, France,
the Netherlands, Estonia, Poland, Italy, Spain, Switzerland
"It hasn't been possible to determine from several
smaller studies conducted so far whether there is a
relationship between consumption of cow's milk infant
formula and the development of type 1 diabetes in children
who are genetically susceptible to the disease,"
said Duane Alexander, M.D., Director of the NICHD. "This
study will be large enough to answer the question once
and for all."
Mothers of infants enrolled in the study will be encouraged
to breast-feed their infants. When the infants are begun
on formula, they will be assigned at random to receive
either a standard cow's milk-based formula or the hydrolyzed
The period of intervention will last until the infants
are 6 months old. However, if mothers choose to breast
feed exclusively for the first six months, then study
formula will be given until the infants are 8 months
old, so that they will have had at least a two-month
exposure to the study formula.
The infants are not expected to develop clinically
evident diabetes during the study. However, the infants
will be followed over a period of 5 years to see whether
or not they develop immunological signs of the very
earliest onset of the disease. The investigators will
be looking for the appearance in the bloodstream of
antibodies to certain proteins of the insulin-producing
cells of the body. The appearance of such antibodies
signals the beginning of a process of destruction of
the body's insulin-producing cells, called beta cells,
found in the pancreas. When most of the beta cells are
destroyed by the body's own immunological attack on
them, diabetes results.
In the United States, the study will be coordinated
by Dorothy J. Becker, M.B.B.Ch, of Children's Hospital
in Pittsburgh, Pennsylvania. In addition to the Pittsburgh
site, other study sites in the United States include
Columbia University in New York City; Washington University
in St. Louis; the University of Washington in Seattle;
the University of California at Los Angeles; and the
Ponce University of Puerto Rico. To learn about participating
in the trial at one of these sites, members of the public
may call Margaret Franciscus at 412-692-5250.
The NICHD is part of the National Institutes of Health,
the biomedical research arm of the Federal government.
The Institute sponsors research on development before
and after birth; maternal, child, and family health;
reproductive biology and population issues; and medical
rehabilitation. NICHD publications, as well as information
about the Institute, are available from the NICHD website,
http://www.nichd.nih.gov, or from the NICHD Clearinghouse,
1-800-370-2943; E-mail: NICHDClearinghouse@mail.nih.gov.