N/A
N=5,156
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00179777 ↗Enrolled (actual)
5,156
Serious AEs
35.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Type 1 Diabetes Mellitus — 82; 91 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrolysed infant formula (Dietary_supplement); Nonhydrolysed infant formula (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Helsinki
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Type 1 Diabetes Mellitus |
82; 91 | — |
| SECONDARY Number of Participants With Diabetes Associated Autoantibodies |
373; 394; 162; 183; 186; 207 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Biological parent and/or full (not half) sibling of the newborn infant had type 1 diabetes as defined by the World Health Organization
- The infant's parent or legal guardians gave signed consent to participate
Exclusion Criteria
- An older sibling of the newborn infant had been included in the TRIGR intervention
- Multiple gestation
- The parents were unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
- The newborn infant had a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
- The gestational age of the newborn infant was less than 35 weeks.
- The infant was older than 7 days at randomization.
- Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centers, the family has no telephone).
- The infant had received any infant formula other than Nutramigen prior to randomization.
- No HLA sample drawn before the age of 8 days.
Data sourced from ClinicalTrials.gov (NCT00179777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.