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Sequencing T-cells in Type I Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02040337
Recruitment Status : Active, not recruiting
First Posted : January 20, 2014
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Detailed Description:
Using a systems biology approach by combining high-throughput sequencing, cytometry, gene expression, transcriptome profiling, HLA typing, single cell analysis, and TCR affinity assays, the investigators will define a set of immune metrics for the prediction or early diagnosis of disease that is superior to the current examination of auto-antibodies, which is a fairly late stage in the disease development. This can also be used to guide therapy in advanced disease.

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus
Study Start Date : April 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes [ Time Frame: 3 month intervals for 2 years. Time to assess effectiveness is 1 year. ]

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Endocrinology clinic patients currently receiving treatment for Type II Diabetes

Inclusion Criteria:

  • Patients must have a current or previous diagnosis of Type I Diabetes (Autoimmune-related T1DA as confirmed by a positive test for glutamic acid decarboxylase (GAD) auto-antibodies. When available, idiopathic T1DB patients with a lack of autoantibodies to GAD will be recruited)
  • Patients must be ≥ 18 years old and ≤55 years old

Inclusion criteria: patients T2D as controls

  • Patients must have a current or previous diagnosis of T2D
  • Patients must be ≥ 18 years old and ≤55 years old

Exclusion Criteria:

• <18 years old; > 55 years old

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02040337

United States, Texas
University of Texas Physicians at Trinity
Austin, Texas, United States, 78701
Sponsors and Collaborators
Seton Healthcare Family
Cancer Prevention Research Institute of Texas
Principal Investigator: Mrinalini Kulkarni-Date, MD Seton Healthcare Family
More Information

Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT02040337     History of Changes
Other Study ID Numbers: CR-14-021
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases