Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk
| ISRCTN | ISRCTN57824306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57824306 |
| ClinicalTrials.gov (NCT) | NCT00179777 |
| Protocol serial number | MCT-49395 |
| Sponsor | John P. Robarts Research Institute (Canada) |
| Funders | Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-49395, US Congress (USA), National Institute of Child health and Human Development (NICHD) (USA), Juvenile Diabetes Research Foundation (JDRF) (Direct) (UK), European Foundation for the Study of Diabetes (EFSD)/JDRF/Novo Nordisk, Finnish Diabetes Research Foundation (Finland), Academy of Finland (Finland), Dutch Diabetes Research Foundation (Netherlands), European Union (EU) |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 12/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Dupre
Scientific
Scientific
John P. Robarts Research Institute
PO Box 5015
100 Perth Dr.
London
N6A 5K8
Canada
| Phone | +1 519 663 2935 |
|---|---|
| john.dupre@lhsc.on.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Trial to Reduce Insulin dependent diabetes mellitus in the Genetically at Risk: a randomised controlled trial |
| Study acronym | TRIGR |
| Study objectives | The hypothesis for this proposal holds that weaning to an extensively hydrolysed infant formula will decrease the incidence of type I diabetes, as it does in all relevant animal models for the disease. |
| Ethics approval(s) | 1. The Hospital District of Helsinki and UUSIMAA, Finland, 19/09/2000 2. The Ethical Committee of Paediatrics and Psychiatry, London Health Sciences Centre, London, Ontario, 02/05/2002 |
| Health condition(s) or problem(s) studied | Type 1 Diabetes Mellitus |
| Intervention | Experimental Arm: Use of infant feed formula, cow milk based, extensively hydrolysed administered when needed in supplementation or substitution for breast milk through 6 - 8 months from birth. (Formulated by MeadJohnson) Control Arm: Use of infant feed formula, cow milk based, non-hydrolysed administered when needed in supplementation or substitution for breast milk through 6 - 8 months from birth. (Formulated by MeadJohnson) Trial details received: 12 Sept 2005 |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Infant feed formulas |
| Primary outcome measure(s) |
Development of diabetes mellitus |
| Key secondary outcome measure(s) |
1. Development of diabetes associated islet antibodies ICA, IAA, GADA Abs, IA-2A Abs |
| Completion date | 31/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 2730 |
| Key inclusion criteria | 1. The biological parents and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the World Health Organization 2. The infants parents or legal guardians give signed consent to participate |
| Key exclusion criteria | 1. An older sibling of the newborn infant has been included in the TRIGR intervention 2. Multiple gestation 3. The parents are unwilling or unable to feed the infant cows milk based products for any reason (e.g. religious, cultural) 4. The newborn infant has a recognisable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies etc. 5. The gestational age of the newborn infant is less than 35 weeks 6. The infant is older than 7 days at randomisation 7. Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centres, the family has no telephone) 8. The infant has received any infant formula other than Nutramigen prior to randomisation 9. No HLA sample drawn before the age of 8 days |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Australia
- Canada
- Czech Republic
- Estonia
- Finland
- Germany
- Hungary
- Italy
- Luxembourg
- Netherlands
- Poland
- Spain
- Sweden
- Switzerland
- United States of America
Study participating centre
John P. Robarts Research Institute
London
N6A 5K8
Canada
N6A 5K8
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/01/2018 | 12/04/2019 | Yes | No |
| Protocol article | protocol | 01/06/2007 | Yes | No | |
| Other publications | recruitment and retention strategies | 01/04/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2019: Publication reference added.
