- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00173628
Autoantibodies in Patients With Type 1 Diabetes Mellitus
Study Overview
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 1.5 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.
Study Type
Enrollment
Contacts and Locations
Study Contact
- Name: Yi-Ching Tung, MD
- Phone Number: 5130 886-2-23123456
- Email: dtped004@yahoo.com.tw
Study Locations
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
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Contact:
- Yi-Ching Tung, MD
- Phone Number: 5130 886-2-23123456
- Email: dtped004@yahoo.com.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pediatric patients with type 1 diabetes
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Yi-Ching Tung, MD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9461700824
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