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TRIGR DART JDRF

 

Trial to Reduce the Incidence of Type 1 Diabetes in the Genetically at Risk (TRIGR)

 

 

Is there a connection between diet in infancy and the development of childhood diabetes?

Can modifying an infant’s diet prevent or reduce the incidence of diabetes in children shown to be genetically at risk?

Type 1 diabetes is due to an abnormal autoimmunity that destroys insulin producing cells in the pancreas.

Clinical work began in Canada in the 80’s where it appeared to show that the immune system in young infants with greater risk of development of Type 1 diabetes is less mature and allows large proteins to leak through pores in the gut lining that normally shrink with age. This sets up a chain reaction that can lead to autoimmune destruction of insulin producing islet cells in the pancreas. If this destructive process can be prevented from starting in the first place we may prevent Type 1 diabetes.


What is TRIGR?

It is the first multinational primary prevention trial in Type 1 diabetes that will assess the relationship on formula consumption to the likelihood of development of Type 1 diabetes.

TRIGR is a randomised, blinded and controlled trial that will use 2 nutritional supplements. These are given to the infants in their first 6-8 months of life if the mother is unable to fully breastfeed. One supplement will contain standard cows milk based formula and the other hydrolysed cow’s milk based formula. “Hydrolysed” refers to the process of breaking down protein in cow’s milk (such as casein) into smaller molecules.

TRIGR will determine if delaying dietary exposure to this intact foreign food protein can reduce the risk of developing Type 1 diabetes in children genetically predisposed to the disease.

This 10 year study is the first diabetes trial to intervene before babies develop antibodies that present prior to Type 1 diabetes development. These antibodies signal the inflammatory process that destroys insulin-creating islet cells in the pancreas and thus Type 1 diabetes develops.

The infants are not expected to develop clinically evident diabetes during the study. However, they will be followed up to see whether they develop immunological signs of the very earliest onset of the disease. TRIGR will be looking for the appearance in the bloodstream of antibodies to certain proteins of the insulin-producing beta cells of the body. The appearance of such antibodies signals the beginning of a process of destruction of the 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.


Where is TRIGR located?

TRIGR has study centres in Australia, Canada, Czech Republic, Estonia, Finland, Germany, Hungary, Italy, The Netherlands, Poland, Spain, Sweden, Switzerland and USA.


What is involved?

• At the birth of the newborn 13mLs of cord blood is collected and sent to Finland to test for high genetic risk of development of Type 1 diabetes.

• Avoidance of all cow’s milk and beef products till 6-8 months of age.

• If the mother is unable to fully breastfeed then the study formula is the only supplement used (which TRIGR will provide).

• Regular interaction and contact with study nurse, nutritionist and doctor during the 10 year follow-up period.

• Regular blood tests, some of which will be looking for the appearance of antibodies to certain proteins of the insulin-producing cells of the body signalling the beginning of the autoimmune process that destroys beta cells, the chemical signs of developing diabetes.


For further information please contact:

Nurse Coordinator
Glenda Fraser
Telephone: 02 9845 3201
Fax: 02 9845 3170
Mobile: 0408 162 559
E-mail: glendaf3@chw.edu.au

Nutrition Coordinator
Ros Bongiorno
Telephone: 02 9845 3147
Fax: 02 9845 3170
E-mail: rosarib2@chw.edu.au