Prospective Assessment in Newborns for Diabetes Autoimmunity | NCT00649246

Studies
Prospective Assessment in Newborns for Diabetes Autoimmunity

NCT00649246

Sponsor

Augusta University

Status

Completed

Last Update Posted

Mar 27, 2018Actual

Enrollment

25,055Actual

Phase

Not provided

Conditions

Type 1 Diabetes
Autoimmunity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U01DK063865	U.S. NIH Grant/Contract		View source

Official Title

1. Prospective Studies in Infants of the Immunopathogenesis of Type 1 Diabetes 2. Consortium for Identification of Environmental Triggers of Type 1 Diabetes: MCG/UF Clinical Center 3. Identification of Serum Protein Markers for Type 1 Diabetes Using Mass-Spectrometry Techniques 4. Validation of Microarray-Based Biomarkers for Type 1 Diabetes 5. Development of Microarray-Based Biomarkers for Type 1 Diabetes 6. Proteomic Changes/Progression of Human Type 1 Diabetes 7. Identification and Validation of Serum Biomarkers for T1D

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1997

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Mar 28, 2008

First Submission Date that Met QC Criteria

Mar 28, 2008

First Posted Date

Apr 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2018

Last Update Posted Date

Mar 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jin-Xiong She, Director Center for Biotechnology and Genomic Medicine, Augusta UniversityPrincipal Investigator

Lead Sponsor

Augusta UniversityOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
University of Florida	OTHER
Emory University	OTHER
Medical University of South Carolina

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25,055Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
autoantibodies against the pancreas and type 1 diabetes		50 years

Secondary Outcomes

Measure	Description	Time Frame
Risk factors for type 1 diabetes		50 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: all are welcome -

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Xiong She, PhD	Augusta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32608	United States
Medical University of South Carolina

Label	URL
PANDA web site	View source

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D001327	Autoimmune Diseases

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided