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Gene Expression Profiling in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330954
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : March 5, 2010
Information provided by:
Children's Mercy Hospital Kansas City

Brief Summary:

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 or disease
Type 1 Diabetes Mellitus

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.

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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gene Expression Profiling in Type 1 Diabetes
Study Start Date : June 2006
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Whole Blood saved frozen for 1 year

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00330954

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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
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Principal Investigator: Karen Kover, PhD Children's Mercy Hospital Kansas City
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Responsible Party: Karen Kover, PhD, Children's Mercy Hospitals and Clinics Identifier: NCT00330954    
Other Study ID Numbers: 06 05-087E
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010
Keywords provided by Children's Mercy Hospital Kansas City:
viral response genes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases