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Sequencing T-cells in Type I Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Seton Healthcare Family
ClinicalTrials.gov Identifier:
NCT02040337
First received: January 16, 2014
Last updated: April 25, 2017
Last verified: April 2017
January 16, 2014
April 25, 2017
April 2014
September 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. ]
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 1
  • 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.
 
Active, not recruiting
40
December 2017
September 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

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

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02040337
CR-14-021
No
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Seton Healthcare Family
Seton Healthcare Family
Cancer Prevention Research Institute of Texas
Principal Investigator: Mrinalini Kulkarni-Date, MD Seton Healthcare Family
Seton Healthcare Family
April 2017

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