Molecular Quantification of Insulin mRNA - Full Text View

Sponsored by:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00324207

Purpose

The objectives of this study are to:

quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects,
determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects,
determine the identity of the white cell responsible for expression of insulin mRNA and
determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.

Condition
Type 1 Diabetes Mellitus

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2008

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:

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.

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:

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

Contacts and Locations

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

Contacts

Contact: Mark Clements, MD, PhD

816-234-1660

mclements@cmh.edu

Locations

United States, Missouri
Children's Mercy Hospital	Recruiting
Kansas City, Missouri, United States, 64108
Contact: Amy Fox, MA 816-802-1208 arfox@cmh.edu
Principal Investigator: Wayne Moore, MD, PhD

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Wayne Moore, MD, PhD

Children's Mercy Hospital

More Information

Responsible Party:	The Children's Mercy Hospital ( Wayne Moore, MD, PhD )
Study ID Numbers:	00006028, 00006028
Study First Received:	May 8, 2006
Last Updated:	January 21, 2008
ClinicalTrials.gov Identifier:	NCT00324207
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

Type 1 diabetes mellitus
Insulin mRNA

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009