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News Releases

For Immediate Release

Children’s Hospital of Pittsburgh Doctor Heads U.S. Contingent in Trial to Prevent Type 1 Diabetes

Dorothy Becker, MBBCh, chief of Endocrinology and Diabetes at Children’s Hospital of Pittsburgh, will head the U.S. contingent of a multinational trial to prevent type 1 diabetes.

The 10-year Trial to Reduce Insulin Dependent Diabetes in the Genetically at Risk (TRIGR) is the first diabetes trial to intervene before babies develop antibodies that signal the inflammatory process that destroys insulin-creating islet cells in the pancreas.

Funds totaling $20 million have been awarded to cover the first five years of the international study from a consortium of the National Institutes of Health (NIH), the Juvenile Diabetes Research Foundation International (JDRF), The European Foundation for the Study of Diabetes, The Canadian Institutes of Health Research and the European Union. After five years, the TRIGR team must submit a renewal of the grant to obtain funding for the remainder of the study. The JDRF will contribute $3 million directly, and through a partnership with EFSD and Novo Nordisk, also will contribute up to $1.2 million. Mead Johnson is supplying the formula for the trail, which will total $5 to $6 million over the course of the trial.

TRIGR will include babies who have a parent or sibling with type 1 diabetes. This randomized multicenter study will determine whether a delay in the exposure of the baby to intact dietary protein can reduce the risk of developing type 1 diabetes (insulin dependent diabetes) in children who are genetically predisposed to getting diabetes. The focus will be on cow milk formula which is usually the first intact protein babies drink or eat. The study is designed to determine whether feeding a hydrolyzed cow milk formula to newborn babies, if and when they are bottle fed, will prevent type 1 diabetes. This formula does not contain intact cow milk or soy protein.

This formula has been shown by researchers in Canada to reduce the incidence of type 1 diabetes in diabetes-prone mice and rats by as much as 80 to 90 percent. The absence of the protein could be the reason. Historical studies of whether early introduction of cow milk or soy based formulas increases the likelihood of developing type 1 diabetes in human beings have produced contradictory results. It is therefore very important that researchers determine whether feeding this formula to babies who receive any formula from birth to 6 to 8 months old will prevent the disease with follow-up to age 10. Babies are included in this study whether they are breast or bottled fed, or both.

Dr. Becker will coordinate the research efforts of six centers: Children’s Hospital of Pittsburgh and the University of Pittsburgh; St. Louis Children’s Hospital and Washington University, St. Louis, Mo.; Washington State University, Seattle; Naomi Berrie Diabetes Center at Columbia-Presbyterian Medical Center and Columbia University, New York, N.Y.; Mattel Children’s Hospital Divisions of General Pediatrics and Neonatology and the University of Southern California, Los Angeles; and San Luis Hospital and Ponce University, Puerto Rico.

Researchers in Finland will coordinate the multinational trial. Australia, Canada, Estonia, France, Germany, Hungary, Italy, Poland, Sardinia, Spain and Sweden also will participate in the trial.

“This international clinical study will investigate environmental factors that may trigger the development of type I diabetes in people at risk and will enhance knowledge about preventive measures for type I diabetes.” said Robert Goldstein, MD, PhD, Chief Scientific Officer of the Juvenile Diabetes Research Foundation. “The knowledge gained by performing this study will prove extremely valuable and could provide a platform for preventive measures that will be tested in future clinical studies.”

Dr. Becker is professor of pediatrics at the University of Pittsburgh School of Medicine and a past president of the western Pennsylvania affiliate of the American Diabetes Association and the National American Diabetes Association Youth Council. She is a former member of the western Pennsylvania board of directors of JDRF. For more than 25 years, Dr. Becker has been actively involved in a large number of diabetes research studies, as well as in the care of children with diabetes. She has achieved national and international recognition for these endeavors.

Individuals who have type 1 diabetes or have a partner or child with type 1 diabetes are interested in having their baby participate in the trial should contact Margaret Franciscus at 412-692-5250 or margaret.franciscus@chp.edu. Please contact us before the baby is to be born.

Contact:
Melanie Tush Finnigan, 412-692-5016, melanie.finnigan@chp.edu.

Last Update
June 17, 2008
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Last Update
June 17, 2008
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