Gene Expression Profiling in Type 1 Diabetes
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.
Status: Completed (N/A). Started on June 1st, 2006.
Enrollment: 64 subjects
Study Type: Observational
Study Design:
- Observational Model: Case Control
- Time Perspective: Prospective
Conditions:
Interventions:
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
- Gender
Both
- Mininum Age
7 Years
- Maximum Age
14 Years
- Healthy Volunteers
No
Resources
Source: Children's Mercy Hospital Kansas City
Authority: United States: Institutional Review Board
Locations
-
Children's Mercy Hospital
Kansas City
Missouri
64108
United States
Officials
Karen Kover, PhD (Principal Investigator, Children's Mercy Hospital)
Sponsors
Children's Mercy Hospital Kansas City (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- March 1st, 2010
- First Received
- March 3rd, 2010
- Last Changed
- March 3rd, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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