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Sequencing T-cells in Type I Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Seton Healthcare Family Identifier:
First received: January 16, 2014
Last updated: April 25, 2017
Last verified: April 2017
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.

Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Seton Healthcare Family:

Primary Outcome Measures:
  • 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. ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 40
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Detailed 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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Endocrinology clinic patients currently receiving treatment for Type II Diabetes

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT02040337

United States, Texas
University of Texas Physicians at Trinity
Austin, Texas, United States, 78701
Sponsors and Collaborators
Seton Healthcare Family
Cancer Prevention Research Institute of Texas
Principal Investigator: Mrinalini Kulkarni-Date, MD Seton Healthcare Family
  More Information

Responsible Party: Seton Healthcare Family Identifier: NCT02040337     History of Changes
Other Study ID Numbers: CR-14-021
Study First Received: January 16, 2014
Last Updated: April 25, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on May 22, 2017