NCT00324207

Molecular Quantification of Insulin mRNA

Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to: 1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects, 2. determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects, 3. determine the identity of the white cell responsible for expression of insulin mRNA and 4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.

Detailed description

Indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. Currently there are no reliable indicators readily available. Insulin mRNA in the white cell fraction of blood has been detected or elevated under several circumstances including: 1. normal animals 2. after islet cell transplantation 3. hyperglycemic induced expression and 4. during induction of diabetes with streptozotocin The investigators propose that quantitative measurement of insulin mRNA may be an accurate, innovative and minimally invasive indicator of beta cell destruction.

Conditions

• Type 1 Diabetes Mellitus

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-05-10
• Last updated: 2010-03-05

Locations

1 site across 1 country: United States