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
Recruitment status was Recruiting
Sponsor:
Georgia Regents University
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
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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 May 23, 2013