Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
None listed
Sponsors
Cancer Prevention Research Institute of Texas
Seton Healthcare Family
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed