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The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up

1, H K Akerblom, J Krischer

  • 1Hospital for Children and Adolescents, University of Helsinki, Biomedicum Helsinki 2 U, PO Box 20, 00014, Helsinki, Finland.

Diabetologia
|December 15, 2010
PubMed

Insights

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study investigated if infant formula impacts type 1 diabetes risk. This international dietary intervention trial is the first of its kind for type 1 diabetes prevention.

Area of Science:

  • Endocrinology
  • Pediatrics
  • Immunology

Background:

  • Type 1 diabetes (T1D) is a significant health concern in genetically predisposed infants.
  • Early life environmental factors, including diet, are hypothesized to play a role in T1D development.
  • The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study addresses this by investigating a specific dietary intervention.

Purpose of the Study:

  • To determine if weaning infants at high genetic risk for type 1 diabetes to a highly hydrolyzed formula reduces their subsequent risk of developing the disease.
  • To assess the feasibility and success of a large-scale, international primary prevention trial for type 1 diabetes.

Main Methods:

  • Recruited newborn infants with a first-degree relative with T1D and specific HLA risk criteria across 15 countries.
  • Encouraged breastfeeding and compared weaning to a hydrolyzed casein formula versus standard cow's milk formula for 6-8 months.
  • Utilized HLA typing at birth to confirm eligibility and monitored participants for disease development.

Main Results:

  • Enrolled 2,160 eligible infants, exceeding the target by 6%.
  • Achieved an 87% retention rate over 5 years with 94% protocol compliance.
  • 80% of enrolled infants were exposed to the study formula.

Conclusions:

  • The TRIGR study demonstrated the feasibility of conducting a large, international dietary intervention trial for type 1 diabetes prevention.
  • The trial's successful implementation provides a robust platform to answer critical questions about T1D primary prevention.
  • Results are pending the final follow-up when the last child reaches 10 years of age in 2017.
Abstract

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