Molecular Quantification of Insulin mRNA

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00324207
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-05-08
• Study First Submitted QC: 2006-05-08
• Study First Posted: 2006-05-10
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-03
• Last Update Posted: 2010-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Male or female subjects ages 1 to 17 years of age
2. Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity
3. Subjects with new onset type 1 diabetes
4. Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes
5. Unrelated nondiabetic controls with no family history of type 1 diabetes
6. Of sufficient size to donate 10ml of blood

Exclusion Criteria

None if subjects meet above inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States