Sequencing T-cells in Type I Diabetes Mellitus

Seton Healthcare Family

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT02040337

CR-14-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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