Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336674
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2006-06-12
Brief Title:
Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Trial of Intranasal Insulin 440 IU in Children and Young Adults at Risk of Type 1 Diabetes Intranasal Insulin Trial II
Status:
COMPLETED
Status Verified Date:
2020-10
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:
INITII
Brief Summary:
In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because the bodys immune system has attacked and destroyed the beta cells It is thought that exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby protective immune cells are stimulated and these then counteract the bad immune cells that damage the beta cells This study aims to determine if intranasal insulin can protect beta cells and stop progression to diabetes in individuals who are at risk
Detailed Description:
Autoimmune diseases are the outcome of dysregulated immune responses to self-antigens Type 1 diabetes T1D previously known as insulin-dependent or juvenile diabetes is an autoimmune disease in which the bodys immune system reacts against and destroys the insulin-producing β cells in the islets of the pancreas T1D classically affects children and young adults Approximately 15 of people with diabetes have this form of the disease and no treatment is currently available to prevent it Asymptomatic individuals in the pre-clinical stage of T1D can be identified by the presence of circulating antibodies to the islet autoantigens proinsulin glutamic acid decarboxylase GAD and tyrosine phosphatase-like insulinoma antigen 2 IA2 Proinsulin is the only autoantigen that is specific for β cells and several lines of evidence demonstrate that it plays a key role in driving autoimmune β-cell destruction
The ability to use self-antigens as tools to induce protective immunity free from the side effects of conventional non-specific immunosuppression is the Holy Grail of autoimmune disease therapy Animal models provide proof-of-concept for such antigen-specific therapy For example in the non-obese diabetic NOD mouse a model of spontaneous T1D transgenic over-expression of proinsulin in antigen-presenting cells in the immune system during development or in transferred bone marrow stem cells completely prevented diabetes On a more practical and translatable level immune tolerance to an antigen can be achieved by administering antigen to the mucosal immune system Thus immune responses to antigen are suppressed by feeding antigen oral tolerance or by administering antigen to the naso-respiratory mucosa
The ability to use self-antigens as tools to induce protective immunity free from the side effects of conventional non-specific immunosuppression is the Holy Grail of autoimmune disease therapy Animal models provide proof-of-concept for such antigen-specific therapy For example in the non-obese diabetic NOD mouse a model of spontaneous T1D transgenic over-expression of proinsulin in antigen-presenting cells in the immune system during development or in transferred bone marrow stem cells completely prevented diabetes On a more practical and translatable level immune tolerance to an antigen can be achieved by administering antigen to the mucosal immune system Thus immune responses to antigen are suppressed by feeding antigen oral tolerance or by administering antigen to the naso-respiratory mucosa
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