Molecular Quantification of Insulin mRNA

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324207
• Other study ID #: 00006028
• Secondary ID: 00006028
• Status: Completed
• Phase: N/A
• First received: May 8, 2006
• Last updated: March 3, 2010
• Start date: February 2006
• Est. completion date: January 2009

Study information

• Verified date: March 2010
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States,