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Molecular Quantification of Insulin mRNA

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00324207
First received: May 8, 2006
Last updated: March 3, 2010
Last verified: March 2010
History of Changes
  Purpose

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.

Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment: 400
Study Start Date: February 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hospital and clinic patients and their siblings.

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324207

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Wayne Moore, MD, PhD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Wayne Moore, MD, PhD, The Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00324207     History of Changes
Other Study ID Numbers: 00006028, 00006028
Study First Received: May 8, 2006
Last Updated: March 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Type 1 diabetes mellitus
Insulin mRNA

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013