Prospective Assessment in Newborns for Diabetes Autoimmunity (PANDA)

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

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