Molecular Quantification of Insulin mRNA

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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:

normal animals
after islet cell transplantation
hyperglycemic induced expression and
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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

None if subjects meet above inclusion criteria

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: May 10, 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.

Published trials that share one or more normalized conditions with this study.

Completed