Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk

ISRCTN	ISRCTN57824306
DOI	https://doi.org/10.1186/ISRCTN57824306
ClinicalTrials.gov number	NCT00179777
Secondary identifying numbers	MCT-49395

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

Study website

Contact information

Dr John Dupre
Scientific

John P. Robarts Research Institute
PO Box 5015
100 Perth Dr.
London
N6A 5K8
Canada

Phone	+1 519 663 2935
Email	john.dupre@lhsc.on.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Patient information can be found at: http://www.TRIGRNorthAmerica.org
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Infant feed formulas
Primary outcome measure	Development of diabetes mellitus
Secondary outcome measures	1. Development of diabetes associated islet antibodies ICA, IAA, GADA Abs, IA-2A Abs 2. Development of cow milk protein antibodies
Overall study start date	01/03/2002
Completion date	31/05/2016

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	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

Sponsor information

John P. Robarts Research Institute (Canada)
Not defined

University of Helsinki, University of Pittsburgh, University of South Florida U.S. NIH funds
for John Robarts Research Institute
P.O. Box 5015
100 Perth Drive
London
N6A 5K8
Canada

"ROR"	https://ror.org/02grkyz14

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada), ref: MCT-49395
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

US Congress (USA)

No information available

National Institute of Child health and Human Development (NICHD) (USA)
Government organisation / National government

Alternative name(s): NICHD
Location: United States of America

Juvenile Diabetes Research Foundation (JDRF) (Direct) (UK)

No information available

European Foundation for the Study of Diabetes (EFSD)/JDRF/Novo Nordisk

No information available

Finnish Diabetes Research Foundation (Finland)

No information available

Academy of Finland (Finland)
Government organisation / Universities (academic only)

Alternative name(s): Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
Location: Finland

Dutch Diabetes Research Foundation (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Dutch Diabetes Research Foundation
Location: Netherlands

European Union (EU)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/06/2007		Yes	No
Other publications	recruitment and retention strategies	01/04/2014		Yes	No
Results article	results	02/01/2018	12/04/2019	Yes	No

Editorial Notes

12/04/2019: Publication reference added.