Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179777
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2005-09-10
Brief Title:
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
TRIGR - Trial to Reduce IDDM in the Genetically at Risk
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIGR
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 was targeted at newborns who are at genetic risk for type 1 diabetes because their mother father andor 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 childrens chances of developing diabetes - as it does in the animal models for diabetes
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
Ia 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 andor 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 cows milk antibodies a measure of cows 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 cows 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 cows milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth
All families were encouraged to breast feed their infants for as long as possible The study infant formula was only used if exclusive breast feeding ceases before 8 months of age
Cord blood for genotyping was 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 remained in the intervention trial All other subjects were withdrawn from the study
All subjects were followed until the youngest subject turns age 10 years
Specific Aims
Ia 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 andor 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 cows milk antibodies a measure of cows 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 cows 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 cows milk based infant formula when needed in supplementation or substitution for breast milk through 6-8 months from birth
All families were encouraged to breast feed their infants for as long as possible The study infant formula was only used if exclusive breast feeding ceases before 8 months of age
Cord blood for genotyping was 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 remained in the intervention trial All other subjects were withdrawn from the study
All subjects were followed until the youngest subject turns age 10 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD040364 | NIH | None | None |
| U01HD042444 | NIH | None | httpsreporternihgovquickSearchU01HD042444 |