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Autoantibodies in Patients With Type 1 Diabetes Mellitus

NCT ID: NCT00173628

Last Updated: 2005-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

1990-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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blood drawing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pediatric patients with type 1 diabetes
Minimum Eligible Age

1 Day

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Yi-Ching Tung, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Ching Tung, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Yi-Ching Tung, MD

Role: primary

Other Identifiers

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9461700824

Identifier Type: -

Identifier Source: org_study_id