Autoreactive Treg in human Type 1 or Type 2 diabetes

Study ID
STU 122011-047

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Mary Estess
214-648-4111
pila.estess@utsouthwestern.edu

Principal Investigator
Mark Siegelman

Summary

Patients within 1 year of first diagnosis of Type 1 or Type 2 diabetes and/or with C-peptide levels of [Less Than] 0.2 nM/L (0.6 ng/mL).will be sought for this study. The study population will be drawn from the uT Southwestern ambulatory Services and Parkland Health and Hospital System. Patients will be asked to donate up to 50 ml of blood on one or more occasions for research purposes. Blood will be drawn at least once and may occur up to 4 times per year, (approximately once every 3 months). initial blood collection will be done by qualified clinic staff. Subsequent blood collection will be done by qualified clinic staff or qualified research personnel. When possible, blood will be drawn in conjunction with routine blood draws ordinarily performed at clinic visit.
This is a study focusing on the characteristics of a small subset of peripheral blood CD4 T cells. no patient treatments or interventions are planned. We will isolate and characterize peripheral blood CD4+CD25+ regulatory T cells, focusing on those cells expressing the T cell adhesion receptor CD44act. We will 1) isolate, expand, and characterize regulatory function of the CD44act T cells; 2) isolate Dna and conduct molecular profiling of T cell receptor (TCR) usage in these cells at the Dna level, as well as expanded CD44act cell lines derived from them; 3) Characterize the Dna conformation in a particular gene region associated with regulatory T cell function; 4) Determine islet antigen reactivity/function of the expanded CD44act lines. Characterization of this population will assist in understanding the failure of effective immune regulation in diabetes and aid in the identification of those antigen-specific Treg most likely to be useful for further therapeutic applications. Results may lead to approaches for personalized cellular therapy in a broad spectrum of autoimmune diseases, including T1D and T2D.

Participant Eligibility

The patient population will be otherwise healthy individuals identified by clinic physician as being within 1 year of diagnosis of Type 1 or Type 2 diabetes and/or having C-peptide levels of < 0.2 nM/L (0.6 ng/mL). (new onset). Patients between the ages of 19 and 65 years interested in participating will be accepted into the study, with exceptions noted below.