Molecular Quantification of Insulin mRNA

March 3, 2010 updated by: Children's Mercy Hospital Kansas City

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital and clinic patients and their siblings.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Wayne Moore, MD, PhD, Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

May 8, 2006

First Submitted That Met QC Criteria

May 8, 2006

First Posted (Estimate)

May 10, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2010

Last Update Submitted That Met QC Criteria

March 3, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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