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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:

Study Description
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.

Condition or disease
Type 1 Diabetes Mellitus

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 Design

Study Type : Observational
Estimated Enrollment : 400 participants
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
Study Start Date : February 2006
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wayne Moore, MD, PhD, The Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00324207     History of Changes
Other Study ID Numbers: 00006028
First Posted: May 10, 2006    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

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