Gene Expression Profiling in Type 1 Diabetes - Full Text View

Sponsored by:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00330954

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

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole Blood saved frozen for 1 year

Estimated Enrollment:	64
Study Start Date:	June 2006
Estimated 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

Contacts

Contact: Karen Kover, PhD

816-983-6640

kkover@cmh.edu

Locations

United States, Missouri
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Amy Fox 816-802-1208 arfox@cmh.edu
Principal Investigator: Karen Kover, PhD

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Karen Kover, PhD

Children's Mercy Hospital

More Information

Responsible Party:	Children's Mercy Hospitals and Clinics ( Karen Kover, PhD )
Study ID Numbers:	06 05-087E
Study First Received:	May 26, 2006
Last Updated:	January 21, 2008
ClinicalTrials.gov Identifier:	NCT00330954
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

viral response genes

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009