TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk

Summary

The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The TRIGR study was targeted at newborns who are at genetic risk for type 1 diabetes because their mother, father and/or full sibling has type 1 diabetes. All families were encouraged to breast feed their infants for as long as possible. Prior to birth, the child was randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study determined whether weaning to a possibly protective infant formula decreases these children's chances of developing diabetes - as it does in the animal models for diabetes.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DIETARY_SUPPLEMENT

Hydrolysed infant formula

Participants in the Hydrolysed infant formula -group received the test formula, casein hydrolysate (Nutramigen™, Mead Johnson Nutritionals), not containing antigenic CM protein, whenever breast milk is not available.

DIETARY_SUPPLEMENT

Nonhydrolysed infant formula

Participants in the Nonydrolysed infant formula -group received the CM protein containing control formula which has an addition (20 %) of Nutramigen, whenever breast milk is not available.

Sponsors & Collaborators

• United States Congress

  collaborator FED

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• European Community (EC)

  collaborator OTHER_GOV

• European Foundation for the Study of Diabetes

  collaborator OTHER

• Mead Johnson Nutrition

  collaborator INDUSTRY

• Academy of Finland

  collaborator OTHER

• Diabetes Research Foundation, Finland

  collaborator OTHER

• Dutch Diabetes Research Foundation

  collaborator OTHER

• University of Helsinki

  lead OTHER

Principal Investigators

• Mikael Knip, MD · University of Helsinki

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

7 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-05-06

Primary Completion

2017-03-31

Completion

2017-09-30

Countries

• United States
• Australia
• Canada
• Czechia
• Estonia
• Finland
• Germany
• Hungary
• Italy
• Luxembourg
• Netherlands
• Poland
• Spain
• Sweden
• Switzerland

Study Locations