T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
A Comparative Study Between the Cytokine Elispot, Tetramer, Immunoblot, and T Cell Proliferation Assays Using Fresh Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
1 other identifier
observational
100
2 countries
14
Brief Summary
Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system which occurs when T cells, which are part of the immune system, damage the insulin secreting cells (islet cells) in the pancreas. Although it is known that T cells are important mediators of the disease, progress in the development of reliable T cell assays has been modest. The purpose of this study is to learn which T cell assays are most reliable and reproducible so that the investigators can improve their understanding about how type 1 diabetes occurs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2005
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedMay 13, 2016
May 1, 2016
September 13, 2005
May 12, 2016
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- To be eligible, individuals with type 1 diabetes must be:
- Diagnosed with type 1 diabetes within one year of first study visit
- years of age at time of first visit
- Weigh \> 40 kg (88 lbs) at time of first visit
- Individuals who will serve as control subjects who do not have type 1 diabetes cannot have a first degree or second degree relative with type 1 diabetes.
You may not qualify if:
- Individuals must not:
- Have any major illness
- Be taking any steroid medications
- If female, should not be pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Childrens Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California, San Francisco
San Francisco, California, 94143-0136, United States
Stanford University Medical Center
Stanford, California, 94305-5208, United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80010, United States
University of Florida
Gainesville, Florida, 32608, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Naomi Berrie Diabetes Center, Columbia University
New York, New York, 10032, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101, United States
University of Bristol
Bristol, BS10 5NB, United Kingdom
Related Publications (6)
Arif S, Tree TI, Astill TP, Tremble JM, Bishop AJ, Dayan CM, Roep BO, Peakman M. Autoreactive T cell responses show proinflammatory polarization in diabetes but a regulatory phenotype in health. J Clin Invest. 2004 Feb;113(3):451-63. doi: 10.1172/JCI19585.
PMID: 14755342BACKGROUNDBensoussan D, Passa P, Canivet J, Levy-Toledano S, Caen J. [Letter: platelet aggregation and assay of Willebrand factor during diabetes mellitus]. Nouv Presse Med. 1975 Jan 18;4(3):195. No abstract available. French.
PMID: 1129082BACKGROUNDMiyazaki I, Cheung RK, Gaedigk R, Hui MF, Van der Meulen J, Rajotte RV, Dosch HM. T cell activation and anergy to islet cell antigen in type I diabetes. J Immunol. 1995 Feb 1;154(3):1461-9.
PMID: 7822811BACKGROUNDNagata M, Kotani R, Moriyama H, Yokono K, Roep BO, Peakman M. Detection of autoreactive T cells in type 1 diabetes using coded autoantigens and an immunoglobulin-free cytokine ELISPOT assay: report from the fourth immunology of diabetes society T cell workshop. Ann N Y Acad Sci. 2004 Dec;1037:10-5. doi: 10.1196/annals.1337.002.
PMID: 15699487BACKGROUNDPeakman M, Tree TI, Endl J, van Endert P, Atkinson MA, Roep BO; Second International Immunology of Diabetes Society Workshop for Standardization ot T-cell Assays in Type 1 Diabetes. Characterization of preparations of GAD65, proinsulin, and the islet tyrosine phosphatase IA-2 for use in detection of autoreactive T-cells in type 1 diabetes: report of phase II of the Second International Immunology of Diabetes Society Workshop for Standardization of T-cell assays in type 1 diabetes. Diabetes. 2001 Aug;50(8):1749-54. doi: 10.2337/diabetes.50.8.1749.
PMID: 11473034BACKGROUNDReijonen H, Mallone R, Heninger AK, Laughlin EM, Kochik SA, Falk B, Kwok WW, Greenbaum C, Nepom GT. GAD65-specific CD4+ T-cells with high antigen avidity are prevalent in peripheral blood of patients with type 1 diabetes. Diabetes. 2004 Aug;53(8):1987-94. doi: 10.2337/diabetes.53.8.1987.
PMID: 15277377BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jay E Skyler, MD
Type 1 Diabetes TrialNet Study Chairman