Sequencing T-cells in Type I Diabetes Mellitus
This trial is active, not recruiting.
|Conditions||diabetes mellitus, type 1, diabetes mellitus, type 2|
|Sponsor||Seton Family of Hospitals|
|Collaborator||Cancer Prevention Research Institute of Texas|
|Start date||April 2014|
|End date||April 2017|
|Trial size||40 participants|
|Trial identifier||NCT02040337, CR-14-021|
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.
|Observational model||case control|
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.
Male or female participants from 18 years up to 55 years old.
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
|Official title||Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus|
|Principal investigator||Mrinalini Kulkarni-Date, MD|
|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.|
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