About TRIGR

Type 1 diabetes develops when the body can no longer produce adequate insulin, the hormone needed for cells to convert glucose to energy. It is called an autoimmune disease because the body’s own immune system destroys the insulin producing cells in the pancreas. Untreated, type 1 diabetes is soon fatal. People with type 1 diabetes need to take insulin artificially, either through injection or with a device known as an insulin pump. Additional information on this condition is available from the Juvenile Diabetes Research Federation website (www.jdrf.org).

The cause of type 1 diabetes has been investigated for several years. It is now believed that environmental factors increase the risk of diabetes in people who are genetically susceptible. If these environmental factors could be identified and eliminated, it might be possible to decrease the number of children who develop type 1 diabetes.

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 at the Hospital for Sick Children in Toronto, Canada, 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. This work has further been developed in Europe, the United States, Australia and South America. Recently, studies have focused on hydrolyzed formulas – those in which a chemical reaction was used to break down the 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. “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,” said Prof. Michael Dosch, Chair of the TRIGR Scientific Advisory Committee and co-founder of the TRIGR effort in Toronto.

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 and international team of physicians and scientists led by Prof. Hans Åkerblom in Helsinki, Finland. These years of development and study set the stage for the multinational TRIGR trial, now underway on three continents.

This study is designed not to interfere with infant feeding practices, except to emphasize and encourage breastfeeding. All mothers who participate in TRIGR will be counseled and supported to exclusively breastfeed their babies for at least the first six months of life in accordance with the World Health Organization 2001 recommendation based on the benefits of breastfeeding for this time period (http://www.who.int/child-adolescent-health/New_Publications/NUTRITION/WHO_CAH_01_24.pdf). However, one problem often encountered by mothers that have type 1 diabetes themselves is that exclusive breastfeeding can not be sustained for medical reasons.

The TRIGR trial will determine whether delayed exposure to intact food proteins will reduce the chances of developing type 1 diabetes later in life. All babies in the study receive the recommendation to breastfeed for at least the first six months of life. If a mother is unable to exclusively breastfeed before the baby is 8 months of age, her child will be randomly assigned to one of two groups. One group of these babies will receive breastfeeding supplements of a trial formula based on extensively hydrolyzed protein; the other group will receive a special trial formula containing a smaller amount of hydrolyzed protein. In hydrolyzed protein, the big protein molecules have been split into very small fragments to provide a source of nutritional amino acids, but the fragments are likely too small to stimulate the immune system.

All TRIGR families will have access and continued support by a local team of pediatricians, nurse and dieticians. Perhaps because of this support and the information provided, more mothers were able to exclusively breastfeed for significantly longer periods than expected in the nationwide Finnish TRIGR pilot study. This effort developed and tested the complex infrastructure required for a very large disease prevention trial such as TRIGR. The trial will also be able to analyze whether, as expected, exclusive breastfeeding can also reduce the risk to children of developing type 1 diabetes.

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