Sequencing T-cells in Type I Diabetes Mellitus



Status:Active, not recruiting
Conditions:Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:4/27/2017
Start Date:April 2014
End Date:December 2017

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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.

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
We found this trial at
1
site
University of Texas Physicians at Trinity
Austin, Texas 78701
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mi
from
Austin, TX
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