T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
12. maj 2016 opdateret af: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The T Cell Validation Study is designed to determine the ability of T cell assays to identify differences in responses from participants with type 1 diabetes compared to normal control subjects, and to compare four different laboratory tests which examine T cells to determine whether the measurements are quantitatively reproducible.
Antibody assays that confirm the presence of type 1 diabetes will be evaluated including: Diabetes Biochemical Autoantibody Assay (anti-GAD65, anti-ICA512, anti-insulin) and Islet Cell Autoantibody testing; genetic testing (deoxyribonucleic acid [DNA] and human leukocyte antigen [HLA]) will also be done to learn more about the T cell assays.
The following T Cell Assays will be conducted in individuals with type 1 diabetes, as well as those without type 1 diabetes:
- Cellular Immunoblot Testing
- T Cell Proliferation Assay
- Tetramer Assay
- Cytokine ELISpot Assay
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bristol, Det Forenede Kongerige, BS10 5NB
- University of Bristol
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California
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Los Angeles, California, Forenede Stater, 90027
- Childrens Hospital of Los Angeles
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San Francisco, California, Forenede Stater, 94143-0136
- University of California, San Francisco
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Stanford, California, Forenede Stater, 94305-5208
- Stanford University Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80010
- Barbara Davis Center for Childhood Diabetes
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Florida
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Gainesville, Florida, Forenede Stater, 32608
- University of Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami School of Medicine
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Riley Hospital for Children
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Joslin Diabetes Center
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota
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New York
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New York, New York, Forenede Stater, 10032
- Naomi Berrie Diabetes Center, Columbia University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh of UPMC
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Texas
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Dallas, Texas, Forenede Stater, 75235
- University of Texas Southwestern Medical Center at Dallas
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Benaroya Research Institute at Virginia Mason
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år til 35 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
To be eligible, individuals with type 1 diabetes must be:
- Diagnosed with type 1 diabetes within one year of first study visit
- 8-35 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.
Exclusion Criteria:
Individuals must not:
- Have any major illness
- Be taking any steroid medications
- If female, should not be pregnant or breastfeeding.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Jay E Skyler, MD, Type 1 Diabetes TrialNet Study Chairman
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Bensoussan 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.
- Miyazaki 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.
- Nagata 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.
- Peakman 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.
- Reijonen 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2005
Studieafslutning (Faktiske)
1. september 2007
Datoer for studieregistrering
Først indsendt
13. september 2005
Først indsendt, der opfyldte QC-kriterier
13. september 2005
Først opslået (Skøn)
21. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2016
Sidst verificeret
1. maj 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tcell (IND) (completed)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .