Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223613
Status:
UNKNOWN
Last Update Posted:
2006-09-19
First Post:
2005-09-13
Brief Title:
Intranasal Insulin for Prevention of Type 1 Diabetes
Sponsor:
University of Turku
Organization:
University of Turku
Study Overview
Official Title:
Intranasal Insulin for Prevention of Type 1 Diabetes in Children Carrying Increased HLA-Conferred Genetic Risk
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Children born in Turku Oulu and Tampere university cities in Finland are screened at birth for HLA alleles that carry increased risk to or protection from development of type 1 diabetes Children carrying increased risk are followed at 3-12-month intervals for development of diabetes-associated autoantibodies Children having at least two types of autoantibodies of the four measured in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 11 trial Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes The primary outcome measure is development of clinical diabetes
Detailed Description:
Children born in Turku Oulu and Tampere university cities in Finland are screened at birth for the HLA-DQB1 and DQA1 alleles that carry increased risk to or protection from development of type 1 diabetes Children carrying increased risk are followed at 3-month intervals until 2 years of age and then at 6-12-month intervals until15 years of age for development of diabetes-associated autoantibodies autoantibodies against islet cells insulin glutamic acid decarboxylase and IA-2 protein Children having at least two types of autoantibodies of the four measured in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 11 trial Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes The primary outcome measure is development of clinical diabetes but serum concentrations of autoantibodies responses to intravenous glucose tolerance test and possible side effects of therapy are also closely monitored
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 |
|---|---|---|---|
| JDRF File 4-1999-731 | None | None | None |