Type 1 Diabetes MellitusNCT00212329
T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
An observational study of Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- T Cell Proliferation and Autoreactivity Assays, Cellular Immunoblot Assays and Tetramer Studies
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Sep 2005to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Individuals must not:
- Have any major illness
- Be taking any steroid medications
- If female, should not be pregnant or breastfeeding.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80010
University of Florida
Gainesville, Florida, 32608
Riley Hospital for Children
Indianapolis, Indiana, 46202
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
University of Miami School of Medicine
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Naomi Berrie Diabetes Center, Columbia University
New York, New York, 10032
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco
San Francisco, California, 94143-0136
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
Stanford University Medical Center
Stanford, California, 94305-5208
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- T Cell Proliferation and Autoreactivity Assays, Cellular Immunoblot Assays, Tetramer Studies, Cytokine ELISPOT
- Keywords
- Type 1 Diabetes, Juvenile Onset Diabetes, Insulin Dependent Diabetes, T1D
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T Cell Proliferation and Autoreactivity AssaysProcedure or surgery
Cellular Immunoblot AssaysProcedure or surgery
Tetramer StudiesProcedure or surgery
Cytokine ELISPOTProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Jay E Skyler, MD, Study chair, Type 1 Diabetes TrialNet Study Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212329
- Sponsor's protocol ID
- Tcell (IND) (completed)
- Status last verified
- May 2016
- First submitted
- 13 Sep 2005
- Last updated
- 13 May 2016
- Results posted
- No
Publications
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.
PubMed 14755342Bensoussan 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.
PubMed 1129082Miyazaki 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.
PubMed 7822811Nagata 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.
PubMed 15699487Peakman 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.
PubMed 11473034Reijonen 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.
PubMed 15277377
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00212329
- Acronym / sponsor ID
- Tcell (IND) (completed)
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes, Juvenile Onset Diabetes, Insulin Dependent Diabetes, T1D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2005
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Have any major illness
- Be taking any steroid medications
- If female, should not be pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T Cell Proliferation and Autoreactivity Assays | Procedure or surgery | – |
| Cellular Immunoblot Assays | Procedure or surgery | – |
| Tetramer Studies | Procedure or surgery | – |
| Cytokine ELISPOT | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 14755342Arif 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.
- Background: PubMed 1129082Bensoussan 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.
- Background: PubMed 7822811Miyazaki 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.
- Background: PubMed 15699487Nagata 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.
- Background: PubMed 11473034Peakman 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.
- Background: PubMed 15277377Reijonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay E Skyler, MD study chair
Type 1 Diabetes TrialNet Study Chairman
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212329, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.