COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212329
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 13, 2016
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Procedure: T Cell Proliferation and Autoreactivity Assays Procedure: Cellular Immunoblot Assays Procedure: Tetramer Studies Procedure: Cytokine ELISPOT

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
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
Study Start Date : September 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   8 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00212329

Layout table for location information
United States, California
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
University of California, San Francisco
San Francisco, California, United States, 94143-0136
Stanford University Medical Center
Stanford, California, United States, 94305-5208
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Naomi Berrie Diabetes Center, Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
United States, Washington
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
United Kingdom
University of Bristol
Bristol, United Kingdom, BS10 5NB
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Layout table for investigator information
Study Chair: Jay E Skyler, MD Type 1 Diabetes TrialNet Study Chairman

Layout table for additonal information Identifier: NCT00212329    
Other Study ID Numbers: Tcell (IND) (completed)
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Type 1 Diabetes
Juvenile Onset Diabetes
Insulin Dependent Diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases