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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN57824306
• Lead Sponsor: John P. Robarts Research Institute (Canada)

Brief Summary

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17550422 2. 2013 recruitment and retention strategies in: http://www.ncbi.nlm.nih.gov/pubmed/24216218 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29297078 (added 12/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Study Completion: 2016-05-31
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2730

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 infant?s parents or legal guardians give signed consent to participate

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 cow?s 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified