Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173628
Status:
UNKNOWN
Last Update Posted:
2005-12-21
First Post:
2005-09-12
Brief Title:
Autoantibodies in Patients With Type 1 Diabetes Mellitus
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
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:
Evaluate the autoantibodies such as glutamic acid decarboxylase GAD65 tyrosine phosphatase IA-2 or ICA125 islet autoantibodies IAA and other associated autoimmune autoantibodies microsomal antibodies thyroglobulin antibodies gastric parietal cell antibodies in patients with type 1 DM
Detailed Description:
Type 1 diabetes mellitus DM is a common disease in pediatric endocrine clinic and epidemiological studies showed the racial variation in the incidence with the highest of 35 cases per 100000 in Finland The incidence of type 1 DM in Taiwan is reported to be 15 per 100000 for the population less than 30 years old While the diagnosis is made the residual islet cell function is only about 20 of normal population Therefore the principle therapy in these patients is insulin therapy lifelong
The pathogenesis of type 1 diabetes mellitus is multifactorial and controversial involving the genetic and environmental factors Type 1 DM is an autoimmune disease which is T cell mediated islet cell destruction Ninety percent of patients with type 1 DM express at least one of the autoantibodies to the islet Antibodies to glutamic acid decarboxylase 65 GAD65 were observed in 60-80 of such patients which were considered the most important autoantigens The autoantibodies disappeared successively after diagnosis and decreased in concentrations over time but titers of antibodies to GAD65 had been observed fluctuated in patients with type 1 DM
The prevalence of GAD antibodies insulin autoantibodies IA-2 tyrosine phosphatase were reported as 45-67 23-67 and 49 respectively in Taiwan Other associated autoimmune disease such as autoimmune thyroiditis were reported as 13-24 Such differences may be caused by the enrolling criteria and different age population Therefore we want to elucidate the role of autoantibodies in the pathogenesis of type 1 DM
The pathogenesis of type 1 diabetes mellitus is multifactorial and controversial involving the genetic and environmental factors Type 1 DM is an autoimmune disease which is T cell mediated islet cell destruction Ninety percent of patients with type 1 DM express at least one of the autoantibodies to the islet Antibodies to glutamic acid decarboxylase 65 GAD65 were observed in 60-80 of such patients which were considered the most important autoantigens The autoantibodies disappeared successively after diagnosis and decreased in concentrations over time but titers of antibodies to GAD65 had been observed fluctuated in patients with type 1 DM
The prevalence of GAD antibodies insulin autoantibodies IA-2 tyrosine phosphatase were reported as 45-67 23-67 and 49 respectively in Taiwan Other associated autoimmune disease such as autoimmune thyroiditis were reported as 13-24 Such differences may be caused by the enrolling criteria and different age population Therefore we want to elucidate the role of autoantibodies in the pathogenesis of type 1 DM
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