TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
|Diabetes Mellitus, Type 1||Dietary Supplement: hydrolysed infant formula Dietary Supplement: nonhydrolysed infant formula|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||TRIGR - Trial to Reduce IDDM in the Genetically at Risk|
- 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 years up to 15 years ]glucose and HbA1C; oral glucose tolerance test at 6, 10 years and in the final year of the study
- 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 years up to 15 years ]diabetes associated antibodies
|Actual Study Start Date:||March 2002|
|Estimated Study Completion Date:||September 2017|
|Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Hydrolysed infant formula
Hydrolysed infant formula
Dietary Supplement: hydrolysed infant formula
hydrolysed infant formula
Placebo Comparator: Nonhydrolysed infant formula
Nonhydrolysed infant formula
Dietary Supplement: nonhydrolysed infant formula
nonhydrolysed infant formula
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.
I.a: To determine if weaning to a casein 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 until the youngest subject turns age 10 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179777
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213-2583|
|Australia, New South Wales|
|Children's Hospital at Westmead|
|Westmead, New South Wales, Australia, 2145|
|Robarts Research Institute|
|London, Canada, N6A 5K8|
|3rd Faculty of Medicine, Charles University, University Hospital Vinohrady|
|Prague, Czechia, 10|
|Tartu University Children's Hospital|
|Tartu, Estonia, 51014|
|University of Helsinki|
|Helsinki, Finland, 00029HUS|
|Kinderkrankenhaus auf der Bult|
|Hannover, Germany, 30173|
|Semmelweis Medical University|
|Budapest, Hungary, 1083|
|St. Michele Hospital|
|Cagliari, Sardinia, Italy, 09134|
|University Campus Bio-Medico of Rome|
|Rome, Italy, 00155|
|Centre Hospitalier de Luxembourg|
|Luxembourg, Luxembourg, 1210|
|Sophia Children's Hospital|
|Rotterdam, Netherlands, 3015 GJ|
|Medical University of Wroclaw|
|Wroclaw, Poland, 50-376|
|Hospital de Cruces|
|Barakaldo, Vizcaya, Spain, 48903|
|Hospital Clinico San Carlos|
|Madrid, Spain, 28040|
|University of Linkoping|
|Linkoping, Sweden, S-58185|
|University Children's Hospital|
|Zurich, Switzerland, CH-8032|
|Principal Investigator:||Hans K Akerblom, MD||Helsinki University|