Prospective Assessment in Newborns for Diabetes Autoimmunity

NCT ID: NCT00649246

Last Updated: 2018-03-27

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

COMPLETED

Total Enrollment

25055 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-07-31

Study Completion Date

2010-08-31

Brief Summary

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This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.

Detailed Description

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This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.

Conditions

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Type 1 Diabetes Autoimmunity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

controls:

healthy individuals with no family history of type 1 diabetes

No interventions assigned to this group

2

high-risk:

Subjects with islet autoantibodies or high-risk diabetes genes

No interventions assigned to this group

3

type 1 diabetes:

subjects with type 1 diabetes

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Jin-Xiong She

Director Center for Biotechnology and Genomic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin Xiong She, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of South Carolina

Columbia, South Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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U01DK063865

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK63865 - PANDA

Identifier Type: -

Identifier Source: org_study_id

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