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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

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.

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Seton Family of Hospitals.