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Prospective Assessment in Newborns for Diabetes Autoimmunity (PANDA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Augusta University.
Recruitment status was:  Recruiting
Sponsor:
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:
Augusta 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 Augusta 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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
Augusta University
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 Augusta University
  More Information

Additional Information:
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 Augusta University:
genetics
type 1 diabetes
biomarkers
autoimmunity

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

ClinicalTrials.gov processed this record on December 09, 2016