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Prospective Assessment in Newborns for Diabetes Autoimmunity (PANDA)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), September 2008
Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Florida
Emory University
Medical University of South Carolina
University of South Carolina
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00649246
  Purpose

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.


Condition
Type 1 Diabetes
Autoimmunity

MedlinePlus related topics: Diabetes Diabetes Type 1
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • autoantibodies against the pancreas and type 1 diabetes [ Time Frame: 50 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk factors for type 1 diabetes [ Time Frame: 50 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

whole blood, DNA, serum, RNA, urine


Estimated Enrollment: 50000
Study Start Date: July 1997
Groups/Cohorts
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


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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria: all are welcome -

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649246

Contacts
Contact: Diane I Hopkins, MS, CCRC 706-721-4161 dhopkins@mcg.edu
Contact: Leigh Steed, RN, CCRA 404-252-0844 lsteed@mcg.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Angie Choate, BS     352-334-0843     choatal@peds.ufl.edu    
Contact: Angela Wilcox, BS     352-334-0843        
Principal Investigator: Desmond Schatz, MD            
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lori Spillers, RN     843-792-8166     spillerl@musc.edu    
Principal Investigator: Louis Luttrel, MD            
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Contact: Joan Thomas     803-251-7870     jthomas@gwm.sc.edu    
Principal Investigator: Elizabeth Mayer-Davis, PhD            
Sponsors and Collaborators
University of Florida
Emory University
Medical University of South Carolina
University of South Carolina
Investigators
Principal Investigator: Jin Xiong She, PhD Medical College of Georgia
  More Information

PANDA web site  This link exits the ClinicalTrials.gov site

Responsible Party: Center for Biotechnology and Genomic Medicine at the Medical College of Georgia ( Jin Xiong She Ph.D. )
Study ID Numbers: DK63865 - PANDA
Study First Received: March 28, 2008
Last Updated: September 16, 2008
ClinicalTrials.gov Identifier: NCT00649246  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
genetics
type 1 diabetes
biomarkers
autoimmunity

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Disease Progression
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009