Prospective Assessment in Newborns for Diabetes Autoimmunity (PANDA)

March 26, 2018 updated by: Jin-Xiong She, Augusta University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

25055

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Gainesville, Florida, United States, 32608
    - University of Florida
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Columbia, South Carolina, United States, 29208
    - University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria: all are welcome -

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Risk factors for type 1 diabetes Time Frame: 50 years	50 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

Medical University of South Carolina

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

Emory University

University of Florida

University of South Carolina

Investigators

Principal Investigator: Jin Xiong She, PhD, Augusta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

PANDA web site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1997

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)