Sequencing T-cells in Type I Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Registration Number
- NCT02040337
- Lead Sponsor
- Seton Healthcare Family
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
• <18 years old; > 55 years old
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Physicians at Trinity
🇺🇸Austin, Texas, United States