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

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.