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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 results.

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 and Hungary.

"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 formula.

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.


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