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Molecular Quantification of Insulin mRNA

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ClinicalTrials.gov Identifier: NCT00324207
Recruitment Status : Completed
First Posted : May 10, 2006
Last Update Posted : March 5, 2010
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date May 8, 2006
First Posted Date May 10, 2006
Last Update Posted Date March 5, 2010
Study Start Date February 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Quantification of Insulin mRNA
Official Title Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospital and clinic patients and their siblings.
Condition Type 1 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 8, 2006)
400
Original Enrollment Same as current
Actual Study Completion Date January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00324207
Other Study ID Numbers 00006028
00006028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wayne Moore, MD, PhD, The Children's Mercy Hospital
Study Sponsor Children's Mercy Hospital Kansas City
Collaborators Not Provided
Investigators
Principal Investigator: Wayne Moore, MD, PhD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date March 2010