Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment hydrolysed vs nonhydrolysed infant formula vs breast feeding
Phase phase 2
Sponsor Children's Hospital of Eastern Ontario
Collaborator US Congress
Start date March 2002
End date February 2017
Trial size 2032 participants
Trial identifier NCT00179777, MCT-49395, U01 HD40364, U01 HD42444

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 is 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 are encouraged to breast feed their infants for as long as possible. Prior to birth, the child is randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study will determine 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention

Primary Outcomes

Measure
Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age.
time frame: 12 and 18 months and annually from 2 to 10 years

Secondary Outcomes

Measure
Diabetes associated islet antibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12 and 18 months of age, and annually from age 2 to 10 years
time frame: 3, 6, 9, 12, 18 months and annually from 2 to 10 years

Eligibility Criteria

Male or female participants up to 7 days old.

Inclusion Criteria: - Biological parent and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the World Health Organization - The infant's parent or legal guardians give signed consent to participate Exclusion Criteria: - An older sibling of the newborn infant has been included in the TRIGR intervention - Multiple gestation - The parents are unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural). - The newborn infant has 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 is less than 35 weeks. - The infant is 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 has received any infant formula other than Nutramigen prior to randomization. - No HLA sample drawn before the age of 8 days.

Additional Information

Official title TRIGR - Trial to Reduce IDDM in the Genetically at Risk
Principal investigator Hans K Akerblom, MD
Description The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes in subjects with risk-associated HLA genotypes and a first degree relative with type 1 diabetes, as it does in all relevant animal models for the disease. Specific Aims: I.a: To determine if weaning to a case in hydrolysate infant formula reduces the frequency of diabetes-predictive auto-antibodies in subjects with risk-associated HLA genotype and a first degree relative with type 1 diabetes (mother, father and/or full sibling). I-b: To determine if weaning to a casein hydrolysate infant formula reduces the frequency of clinical diabetes in subjects with risk-associated HLA genotype and an affected first degree relative. A secondary aim is to determine relationships between cow's milk antibodies, a measure of cow's milk exposure, and diabetes-associated auto-antibodies. The mother of the unborn child is recruited during pregnancy. Randomization to one of two infant formulas takes place before birth (after 35 weeks gestation) or immediately after birth. Experimental Arm: Use of extensively hydrolysed cow's milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth. Control Arm: Use of non-hydrolysed cow's milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth. All families are encouraged to breast feed their infants for as long as possible. The study infant formula is only used if exclusive breast feeding ceases before 8 months of age. Cord blood for genotyping is obtained at birth, or failing that from a heel prick by 7 days of age. Only subjects with genotypes indicating increased genetic risk for type 1 diabetes remain in the intervention trial. All other subjects are withdrawn from the study. All subjects will be followed for 10 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario.