NCT00649246

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,055

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1997

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

13.1 years

First QC Date

March 28, 2008

Last Update Submit

March 26, 2018

Conditions

Type 1 DiabetesAutoimmunity

Keywords

geneticstype 1 diabetesbiomarkersautoimmunity

Outcome Measures

Primary Outcomes (1)

  • autoantibodies against the pancreas and type 1 diabetes

    50 years

Secondary Outcomes (1)

  • Risk factors for type 1 diabetes

    50 years

Study Arms (3)

1

controls: healthy individuals with no family history of type 1 diabetes

2

high-risk: Subjects with islet autoantibodies or high-risk diabetes genes

3

type 1 diabetes: subjects with type 1 diabetes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

newborns, young children, adults with or without type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Florida

Gainesville, Florida, 32608, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, DNA, serum, RNA, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Study Officials

  • Jin Xiong She, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Center for Biotechnology and Genomic Medicine

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

July 1, 1997

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

US(3)