- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00212329
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
Studieoversikt
Status
Forhold
Detaljert 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
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90027
- Childrens Hospital of Los Angeles
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San Francisco, California, Forente stater, 94143-0136
- University of California, San Francisco
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Stanford, California, Forente stater, 94305-5208
- Stanford University Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80010
- Barbara Davis Center for Childhood Diabetes
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Florida
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Gainesville, Florida, Forente stater, 32608
- University of Florida
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Miami, Florida, Forente stater, 33136
- University of Miami School of Medicine
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Riley Hospital for Children
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Joslin Diabetes Center
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota
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New York
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New York, New York, Forente stater, 10032
- Naomi Berrie Diabetes Center, Columbia University
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Children's Hospital of Pittsburgh of UPMC
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Texas
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Dallas, Texas, Forente stater, 75235
- University of Texas Southwestern Medical Center at Dallas
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Washington
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Seattle, Washington, Forente stater, 98101
- Benaroya Research Institute at Virginia Mason
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Bristol, Storbritannia, BS10 5NB
- University of Bristol
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Jay E Skyler, MD, Type 1 Diabetes TrialNet Study Chairman
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Tcell (IND) (completed)
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