Sequencing T-cells in Type I Diabetes Mellitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seton Family of Hospitals
Sponsor:
Collaborators:
Seton Clinical Research Pilot Grant Program
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT02040337
First received: January 16, 2014
Last updated: September 29, 2014
Last verified: September 2014

January 16, 2014
September 29, 2014
April 2014
April 2017   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02040337 on ClinicalTrials.gov Archive Site
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Sequencing T-cells in Type I Diabetes Mellitus
Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific 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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

Endocrinology clinic patients currently receiving treatment for Type II Diabetes

Diabetes Mellitus, Type 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2017
April 2017   (final data collection date for primary outcome measure)

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
  • Male
  • Caucasian

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
  • Male

Exclusion Criteria:

  • Non-Caucasian
  • Female
  • <18 years old; > 55 years old
Male
18 Years to 45 Years
Yes
Contact: Poppy Poth 512-324-1000 ext 89612 pepoth@seton.org
United States
 
NCT02040337
CR-14-021
No
Seton Family of Hospitals
Seton Family of Hospitals
  • Seton Clinical Research Pilot Grant Program
  • Cancer Prevention Research Institute of Texas
Principal Investigator: Mrinalini Kulkarni-Date, MD Seton Family of Hospitals
Seton Family of Hospitals
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP