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June 10, 2002: Canadian Institutes of Health Research Press Release


For immediate release 2002-18

TORONTO (June 10, 2002) - The Honourable Anne McLellan, Minister of Health and Dr. Alan Bernstein, President of the Canadian Institutes of Health Research launched today at The Hospital for Sick Children (HSC) the Canadian component of a multinational clinical trial aimed at reducing the incidence of Type 1 diabetes in children.

Type 1 diabetes, usually diagnosed in children, is due to abnormal autoimmunity that destroys insulin producing cells in the pancreas. Insulin is an essential hormone that regulates energy production from sugar and fat. Approximately 200,000 Canadians have Type I diabetes and require daily insulin injections. Type 1 diabetes hardens small blood vessels and is the leading cause of blindness, heart and kidney disease, stroke and loss of limbs.

TRIGR (Trial to Reduce Insulin-Dependent Diabetes in the Genetically at Risk) is the largest clinical trial ever conducted in Canada and one of the largest pediatric trials in the world. Based out of the Robarts Research Institute in London, Ontario, this trial will determine if delaying dietary exposure to intact foreign food proteins can reduce the risk of developing Type 1 diabetes in children who are genetically predisposed to the disease.

The total budget for this 10-year study will exceed $50 million of which the Canadian component includes $10 million from CIHR and a significant contribution from the Juvenile Diabetes Research Foundation. Other funders include the US National Institutes of Health and several European agencies. The Mead-Johnson Division of Bristol-Myers-Squibb, Evansville, Illinois supported the development of the TRIGR trial from its inception to the present trial, and supplies all formulas worldwide. The Hospital for Sick Children Foundation provided grants to support the national and international trial development.

"The potential outcome of this clinical trial is extraordinary in terms of improving the health of our children, reducing the burden of illness in our health care system and advancing global health," said Minister McLellan. "One of the most effective ways to reduce the incidence of diseases such as diabetes is to focus on preventative measures such as this trial which offers great hope for those suffering from diabetes."

"We are entering a science-based age in health research and health care. The TRIGR trial is the first concerted scientific effort to tackle diabetes with a practical, primary prevention measure," said Dr. Bernstein. "This clinical trial is a shining example of applying science in the real world -- a major priority of CIHR."

Approximately 6000 families with a history of Type 1 diabetes and expecting a baby will be recruited for this study. When babies are weaned from breastfeeding, they will receive infant formulas that contain no, or a reduced amount of, intact foreign food proteins typically found in baby formulas. TRIGR will enroll babies from across 17 countries. Recruitment will span two years, with follow-up for 10 years.

Over 40 centres in Canada, the United States, Europe and Australia will be involved in TRIGR. The coordinating centre for this international study is in Finland, led by Dr. Hans K. Åkerblom. The 14 Canadian centres involved in the trials are: Calgary, Edmonton, Halifax/PEI, London, Montreal, Ottawa/Kingston, Quebec City, Saint John, St. John's, Toronto, Vancouver, Winnipeg/Saskatoon. The national study will be led by Dr. John Dupré (Robarts Research Institute) with Dr. Michael Dosch (The Hospital for Sick Children), Dr. William Fraser (Université Laval), Dr. Margaret Lawson (Children's Hospital of Eastern Ontario), Dr. Jeffery Mahon (University of Western Ontario) and Dr. Shayne P. Taback (University of Manitoba), and an additional 34 Canadian investigators at the clinical centres.

"This is the first trial that attempts to prevent the development of diabetes in its earliest beginnings," said Dr. John Dupré, co-principal investigator of the Canadian study. "TRIGR is an excellent example of bench-to-bedside research. Substantial evidence from basic laboratory research, and animal and human pilot studies, helped to develop this trial over the past decade."

This clinical trial builds on basic research that began at Toronto's Hospital for Sick Children in the 1980s. "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. Our study formula does not contain such proteins and gives the immune system time to catch up in development," said Dr. Michael Dosch, the basic science chair of TRIGR, co-principal investigator of the Canadian study, and a senior scientist at HSC.

"This international effort will investigate potential environmental factors that affect people at risk of developing Type-1 diabetes," said Ron Forbes, President & CEO of the Juvenile Diabetes Research Foundation. "Regardless of the study's outcome, the collaborations fostered in this study should prove immensely valuable in future efforts to prevent Type 1 diabetes."

CIHR is Canada's premier agency for funding health research. Its objective is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products, and a strengthened health care system.

For more information on enrolling in TRIGR, call 1-888-STOP-T1D
or visit the TRIGR website at www.trigr.org.

Janet Weichel, CIHR Communications, (613) 447-4794
Laura Greer, The Hospital for Sick Children, (416) 813-5046
Farah Mohamed, Minister McLellan's Office (613) 957-0200

Ce document est également disponible en français.


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