Sequencing T-cells in Type I Diabetes Mellitus

This study is not yet open for participant recruitment.
Verified January 2014 by Seton Family of Hospitals
Sponsor:
Collaborators:
Seton Clinical Research Pilot Grant Program
Cancer Prevention Institute of Texas
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT02040337
First received: January 16, 2014
Last updated: February 25, 2014
Last verified: January 2014
  Purpose

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.


Condition
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 Family of Hospitals:

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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 60
Study Start Date: April 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Endocrinology clinic patients currently receiving treatment for Type II Diabetes

Criteria

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 ≤45 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 ≤45 years old
  • Male

Exclusion Criteria:

  • Non-Caucasian
  • Female
  • <18 years old; > 45 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02040337

Contacts
Contact: Poppy Poth 512-324-1000 ext 89612 pepoth@seton.org

Locations
United States, Texas
University of Texas Physicians at Trinity Not yet recruiting
Austin, Texas, United States, 78701
Contact: Poppy Poth    512-324-1000 ext 89612      
Principal Investigator: Mrinalini Kulkarni-Date, MD         
Sponsors and Collaborators
Seton Family of Hospitals
Seton Clinical Research Pilot Grant Program
Cancer Prevention Institute of Texas
Investigators
Principal Investigator: Mrinalini Kulkarni-Date, MD Seton Family of Hospitals
  More Information

No publications provided

Responsible Party: Seton Family of Hospitals
ClinicalTrials.gov Identifier: NCT02040337     History of Changes
Other Study ID Numbers: CR-14-021
Study First Received: January 16, 2014
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014