Sequencing T-cells in Type I Diabetes Mellitus

N/ACompletedNCT02040337

Seton Healthcare Family40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Physicians at Trinity

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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