Sequencing T-cells in Type I Diabetes Mellitus

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Research 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 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014