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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00179777

Run by

University of Helsinki

People needed

5156

Starts

2002-05-06

Expected to finish

2017-09-30

Last updated by the study team

2021-07-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of South Florida — Tampa, Florida, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Robarts Research Institute — London, Ontario, Canada
• 3rd Faculty of Medicine, Charles University, University Hospital Vinohrady — Prague, Czechia
• Tartu University Children's Hospital — Tartu, Estonia
• University of Helsinki — Helsinki, Finland
• Kinderkrankenhaus auf der Bult — Hanover, Germany
• Semmelweis Medical University — Budapest, Hungary
• St. Michele Hospital — Cagliari, Sardinia, Italy
• University Campus Bio-Medico of Rome — Rome, Italy
• Centre Hospitalier de Luxembourg — Luxembourg, Luxembourg
• Sophia Children's Hospital — Rotterdam, Netherlands
• Medical University of Wroclaw — Wroclaw, Poland
• Hospital de Cruces — Barakaldo, Vizcaya, Spain
• Hospital Clinico San Carlos — Madrid, Spain
• University of Linkoping — Linköping, Sweden
• University Children's Hospital — Zurich, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.