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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 2009
First Received: March 28, 2008   Last Updated: September 14, 2009   History of Changes
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: 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

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

Resource links provided by NLM:


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

Additional Information:
No publications provided

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 14, 2009
ClinicalTrials.gov Identifier: NCT00649246     History of Changes
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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010