Prospective Assessment in Newborns for Diabetes Autoimmunity (PANDA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Georgia Regents University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Florida
Emory University
Medical University of South Carolina
University of South Carolina
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00649246
First received: March 28, 2008
Last updated: May 12, 2011
Last verified: May 2011
  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: Observational Model: Cohort
Time Perspective: 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 Georgia Regents University:

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

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
Georgia Regents University
University of Florida
Emory University
Medical University of South Carolina
University of South Carolina
Investigators
Principal Investigator: Jin Xiong She, PhD Georgia Regents University
  More Information

Additional Information:
No publications provided

Responsible Party: Jin Xiong She Ph.D., Center for Biotechnology and Genomic Medicine at the Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00649246     History of Changes
Other Study ID Numbers: DK63865 - PANDA, U01DK063865
Study First Received: March 28, 2008
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by Georgia Regents University:
genetics
type 1 diabetes
biomarkers
autoimmunity

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

ClinicalTrials.gov processed this record on April 23, 2014