Gene Expression Profiling in Type 1 Diabetes

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00330954
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Study Start: 2006-06
• Study Completion: 2008-04
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-03
• Last Update Posted: 2010-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States