title: The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.
abstract: OBJECTIVE
  The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study was designed to establish whether weaning to a highly hydrolysed formula in infancy subsequently reduces the risk of type 1 diabetes.
  
  
  METHODS
  The study population comprises newborn infants who have first-degree relatives with type 1 diabetes and meet the increased risk HLA inclusion, but not exclusion criteria. The study is being performed in 15 countries in three continents. First-degree relatives of patients with type 1 diabetes were identified from diabetes clinics, diabetes registries, and from other endocrinology or obstetrics offices and websites. HLA typing was performed at birth from cord or heel stick blood, and the results sent to the study's Data Management Unit within 2 weeks for communication of eligibility to the clinical study centre. All mothers recruited were encouraged to breastfeed. The intervention lasted for 6 to 8 months, and weaning formulas based on hydrolysed casein and standard cow's milk were compared.
  
  
  RESULTS
  TRIGR recruited 5,606 infants, of whom 2,160 were enrolled as eligible participants, 6% more than the target of 2,032. Of those enrolled, 80% were exposed to the study formula. The overall retention rate over the first 5 years is 87%, with protocol compliance at 94%. The randomisation code will be opened when the last recruited child turns 10 years of age, i.e. in 2017.
  
  
  CONCLUSIONS
  The TRIGR experience demonstrates the feasibility and successful implementation of an international dietary intervention study. TRIGR is the first ever primary prevention trial for type 1 diabetes and, if completed successfully, will provide a definite answer to the research question.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00179777
  
  
  BACKGROUND
  The study was funded by the National Institute of Child Health and Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) (grant numbers HD040364, HD042444 and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International and the Commission of the European Communities (specific RTD programme 'Quality of Life and Management of Living Resources', contract number QLK1-2002-00372 'Diabetes Prevention'. Other funding came from the EFSD/JDRF/Novo Nordisk Focused Research Grant, Academy of Finland, Dutch Diabetes Research Foundation and Finnish Diabetes Research Foundation).
authors.affiliation: Hospital for Children and Adolescents, University of Helsinki, Biomedicum Helsinki 2 U, PO Box 20, 00014, Helsinki, Finland.
authors.forename: H K
authors.initials: HK
authors.lastname: Akerblom
authors.forename: J
authors.initials: J
authors.lastname: Krischer
authors.forename: S M
authors.initials: SM
authors.lastname: Virtanen
authors.forename: C
authors.initials: C
authors.lastname: Berseth
authors.forename: D
authors.initials: D
authors.lastname: Becker
authors.forename: J
authors.initials: J
authors.lastname: Dupré
authors.forename: J
authors.initials: J
authors.lastname: Ilonen
authors.forename: M
authors.initials: M
authors.lastname: Trucco
authors.forename: E
authors.initials: E
authors.lastname: Savilahti
authors.forename: K
authors.initials: K
authors.lastname: Koski
authors.forename: E
authors.initials: E
authors.lastname: Pajakkala
authors.forename: M
authors.initials: M
authors.lastname: Fransiscus
authors.forename: G
authors.initials: G
authors.lastname: Lough
authors.forename: B
authors.initials: B
authors.lastname: Bradley
authors.forename: M
authors.initials: M
authors.lastname: Koski
authors.forename: M
authors.initials: M
authors.lastname: Knip
mesh_terms: D000818:Animals; D001942:Breast Feeding; D002364:Caseins / Q000737:chemistry; D003922:Diabetes Mellitus, Type 1 / Q000517:prevention & control*; D006801:Humans; D041943:Infant Formula / Q000008:administration & dosage* / Q000737:chemistry; D007231:Infant, Newborn; D008892:Milk; D012107:Research Design
chemical_list: D002364:Caseins