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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00324207

Enrollment

400

Registered

2006-05-10

Start date

2006-02-28

Completion date

2009-01-31

Last updated

2010-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetes mellitus, Insulin mRNA

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

Yes

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

Countries

United States

Outcome results