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OpenTrials
Completed

NCT Number: NCT00330954

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.

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Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Important dates

Study start
2006
Study completion
2008
First posted
May 29, 2006
Registry last updated
Mar 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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