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NCT02040337 Clinical Trial

Sequencing T-cells in Type I Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02040337
Other study ID # CR-14-021
Secondary ID
Status Completed
Phase
First received January 16, 2014
Last updated April 16, 2018
Start date April 2014
Est. completion date December 13, 2017

Study information
Verified date April 2018
Source Seton Healthcare Family
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 13, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Texas Physicians at Trinity Austin Texas

Sponsors (2)
Lead Sponsor Collaborator
Seton Healthcare Family Cancer Prevention Research Institute of Texas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes 3 month intervals for 2 years. Time to assess effectiveness is 1 year.
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