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Gene Expression Profiling in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00330954
First received: May 26, 2006
Last updated: March 3, 2010
Last verified: March 2010
History of Changes
  Purpose

One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes and their products that are associated with T1DM. Characterization of such genes and their products can aid in developing new tools for risk assessment, development of new prevention strategies and monitoring progression of disease.

Study design: Descriptive, basic science pilot study. The results of this pilot study will be used to help design a much larger study to address the importance of viral response and autoimmune diabetes.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Gene Expression Profiling in Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Biospecimen Retention:   Samples With DNA

Whole Blood saved frozen for 1 year


Estimated Enrollment: 64
Study Start Date: June 2006
Study Completion Date: April 2008
Detailed Description:

The hypothesis is that viral responsive genes are up-regulated prior to the onset of symptoms of Type 1 Diabetes (T1DM) and may correlate with increased expression of interferon alpha.

Both genetic and environmental factors contribute to risk of development of T1DM. There are a number of conflicting reports associating viral infections and T1DM in genetically susceptible individuals and causality has not been proven. Viruses may not have a large role in the initiation of islet cell autoimmunity but more of a role in acceleration of the disease leading to overt symptoms. There are no studies describing viral responsive gene expression in these individuals.

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male and female subjects 7-14 years of age

  • New onset T1DM
  • Five years post onset of T1DM
Criteria

Inclusion Criteria:

  • Male and female subjects 7-14 years of age
  • New onset T1DM
  • Five years post onset of T1DM
  • Participant in the TrialNet initiative and either antibody positive or antibody negative sibling control
  • Body weight sufficient to tolerate an additional 15ml (1 tbsp) blood loss

Exclusion Criteria:

  • Subjects who do not meet the criteria above
  • Subjects who have received steroids or other immunosuppressive therapy within the 6 months prior to enrollment into the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330954

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Karen Kover, PhD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Karen Kover, PhD, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00330954     History of Changes
Other Study ID Numbers: 06 05-087E
Study First Received: May 26, 2006
Last Updated: March 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
viral response genes

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

ClinicalTrials.gov processed this record on May 19, 2013