Sequencing T-cells in Type I Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Physicians at Trinity

Austin, Texas, 78701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Seton Healthcare Family

Other

Collaborators

Cancer Prevention Research Institute of Texas

Registry information

Official study title

Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jan 20, 2014
Registry last updated: Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed