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Trial record 1 of 1 for:    NCT00179777
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TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk

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ClinicalTrials.gov Identifier: NCT00179777
Recruitment Status : Unknown
Verified July 2017 by Margaret Lawson, Children's Hospital of Eastern Ontario.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
US Congress
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Canadian Institutes of Health Research (CIHR)
Juvenile Diabetes Research Foundation
European Foundation for the Study of Diabetes
European Community (EC)
Mead Johnson Nutrition
Diabetes Research Foundation, Finland
Academy of Finland
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Margaret Lawson, Children's Hospital of Eastern Ontario

Brief Summary:
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 is 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 are encouraged to breast feed their infants for as long as possible. Prior to birth, the child is randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study will determine 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Dietary Supplement: hydrolysed infant formula Dietary Supplement: nonhydrolysed infant formula Not Applicable

Detailed Description:

The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes in subjects with risk-associated HLA genotypes and a first degree relative with type 1 diabetes, as it does in all relevant animal models for the disease.

Specific Aims:

I.a: To determine if weaning to a casein hydrolysate infant formula reduces the frequency of diabetes-predictive auto-antibodies in subjects with risk-associated HLA genotype and a first degree relative with type 1 diabetes (mother, father and/or full sibling).

I-b: To determine if weaning to a casein hydrolysate infant formula reduces the frequency of clinical diabetes in subjects with risk-associated HLA genotype and an affected first degree relative.

A secondary aim is to determine relationships between cow's milk antibodies, a measure of cow's milk exposure, and diabetes-associated auto-antibodies.

The mother of the unborn child is recruited during pregnancy. Randomization to one of two infant formulas takes place before birth (after 35 weeks gestation) or immediately after birth.

Experimental Arm: Use of extensively hydrolysed cow's milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth.

Control Arm: Use of non-hydrolysed cow's milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth.

All families are encouraged to breast feed their infants for as long as possible. The study infant formula is only used if exclusive breast feeding ceases before 8 months of age.

Cord blood for genotyping is obtained at birth, or failing that from a heel prick by 7 days of age. Only subjects with genotypes indicating increased genetic risk for type 1 diabetes remain in the intervention trial. All other subjects are withdrawn from the study.

All subjects will be followed until the youngest subject turns age 10 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: TRIGR - Trial to Reduce IDDM in the Genetically at Risk
Actual Study Start Date : March 2002
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydrolysed infant formula
Hydrolysed infant formula
Dietary Supplement: hydrolysed infant formula
hydrolysed infant formula

Placebo Comparator: Nonhydrolysed infant formula
Nonhydrolysed infant formula
Dietary Supplement: nonhydrolysed infant formula
nonhydrolysed infant formula




Primary Outcome Measures :
  1. Type 1 diabetes mellitus assessed by (1) blood glucose and HbA1c at 12 and 18 months of age, and annually from age 2 to 10 years, and (2) oral glucose tolerance test at 6 and 10 years of age. [ Time Frame: 12 and 18 months and annually from 2 years up to 15 years ]
    glucose and HbA1C; oral glucose tolerance test at 6, 10 years and in the final year of the study


Secondary Outcome Measures :
  1. Diabetes associated islet antibodies (ICA, IAA, GADA, IA-2A) at 3, 6, 9, 12 and 18 months of age, and annually from age 2 to 10 years [ Time Frame: 3, 6, 9, 12, 18 months and annually from 2 years up to 15 years ]
    diabetes associated antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biological parent and/or full (not half) sibling of the newborn infant has type 1 diabetes as defined by the World Health Organization
  • The infant's parent or legal guardians give signed consent to participate

Exclusion Criteria:

  • An older sibling of the newborn infant has been included in the TRIGR intervention
  • Multiple gestation
  • The parents are unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
  • The newborn infant has 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 is less than 35 weeks.
  • The infant is 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 has received any infant formula other than Nutramigen prior to randomization.
  • No HLA sample drawn before the age of 8 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179777


Locations
Show Show 17 study locations
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
US Congress
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Canadian Institutes of Health Research (CIHR)
Juvenile Diabetes Research Foundation
European Foundation for the Study of Diabetes
European Community (EC)
Mead Johnson Nutrition
Diabetes Research Foundation, Finland
Academy of Finland
Dutch Diabetes Research Foundation
Investigators
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Principal Investigator: Hans K Akerblom, MD University of Helsinki
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Margaret Lawson, Site Investigator, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00179777    
Other Study ID Numbers: MCT-49395
U01HD040364 ( U.S. NIH Grant/Contract )
U01HD042444 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Margaret Lawson, Children's Hospital of Eastern Ontario:
Diabetes Mellitus, Type 1
Genetic Predisposition to Disease
Infant Nutrition
Primary Prevention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases