Gene Expression Profiling in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Gene Expression Profiling in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330954
• Other study ID #: 06 05-087E
• Status: Completed
• Phase: N/A
• First received: May 26, 2006
• Last updated: March 3, 2010
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2010
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States,