Ignite Creation Date:
2024-05-05 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00570102
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2007-12-07
Brief Title:
Nutritional Prevention Pilot Trial for Type 1 Diabetes
Sponsor:
University of Helsinki
Organization:
University of Helsinki
Study Overview
Official Title:
Trial to Reduce IDDM in the Genetically at Risk TRIGR the Pilot Study
Status:
COMPLETED
Status Verified Date:
2012-11
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:
MIP
Brief Summary:
The overall objective of the study is to assess whether complete avoidance of cows milk CM proteins for at least the first 6 months of life prevents type 1 diabetes insulin-dependent diabetes mellitus IDDM in genetically susceptible children who have a mother biological father or sibling affected by type 1 diabetes
Detailed Description:
Among the environmental factors leading to type 1 diabetes in childhood the most important are certain viral infections and possibly some dietary factors Among the latter cows milk proteins are of special interest They have been shown to be involved in the pancreatic beta-cell lesion in animal experiments In humans there are some indications of a role of early exposure to cows milk proteins as a risk factor for later type 1 diabetes The hypothesis has not been confirmed but a randomized controlled double-blinded intervention trial should provide a definite answer
This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity andor type 1 diabetes in children who have an increased genetic risk for the disease by administering in infancy after breast feeding until the age of 6-8 months such a formula in which the cows milk proteins have been hydrolyzed to smaller peptides The children in the control group carrying a similar increased genetic risk will receive a conventional cows milk based formula
This project is a pilot multicenter trial comprising 15 hospitals in Finland
This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity andor type 1 diabetes in children who have an increased genetic risk for the disease by administering in infancy after breast feeding until the age of 6-8 months such a formula in which the cows milk proteins have been hydrolyzed to smaller peptides The children in the control group carrying a similar increased genetic risk will receive a conventional cows milk based formula
This project is a pilot multicenter trial comprising 15 hospitals in Finland
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| BHM4-CT96-0233 | None | None | None |