Imaging Inflammation in Autoimmune Diabetes - Full Text View

Sponsors and Collaborators:	Joslin Diabetes Center Massachusetts General Hospital AMAG Pharmaceuticals, Inc.
Information provided by:	Joslin Diabetes Center
ClinicalTrials.gov Identifier:	NCT00585936

Purpose

The purpose of this study is to determine whether magnetic resonance imaging (MRI) with ferumoxtran-10 can be used to detect changes in the pancreas associated with autoimmune diabetes.

Condition
Diabetes Mellitus, Type 1

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Magnetic Nanoparticle Enhanced Imaging in Autoimmune Diabetes

Further study details as provided by Joslin Diabetes Center:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2011

Groups/Cohorts
1 Normal controls without evidence of diabetes or islet specific autoimmunity
2 Individuals within 6 months of diagnosis with type 1 diabetes
3 Individuals at high risk for the development of type 1 diabetes
4 Individuals with longstanding autoimmune diabetes

Detailed Description:

Approximately one million individuals are afflicted with autoimmune Type 1 diabetes mellitus (T1DM) in the United States. This disease results from the autoimmune destruction of the insulin-producing beta-cells of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically occult with localized pancreatic inflammation characterized by a lymphocytic infiltration of the pancreatic islets, termed insulitis, which leads to beta-cell specific destruction of the islets. This is often followed by the clinically overt phase that ensues when the bulk of beta cells have been destroyed and the pancreas is no longer able to produce sufficient insulin to maintain glycemic control. The purpose of this study is to assess the ability of magnetic resonance imaging with ferumoxtran-10, a functional molecular imaging agent consisting of iron oxide nanoparticles, to detect changes in the pancreas associated with the insulitis of T1DM.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

The study population is to be drawn from the general population, diabetes clinic population, and at risk individuals as previously identified in prior family studies.

Criteria

Inclusion Criteria:

Recent onset type 1 diabetes as defined by clinical diagnosis within the last 6 months and age less than 30 or at least one islet autoantibody marker (GAD, IAA, or IA-2).

or

High risk of pre-type 1 diabetes as defined by first degree family relative with type 1 diabetes and at least one islet autoantibody marker (GAD, IAA, or IA-2).

or

Individuals with established type 1 diabetes of greater than 6 months duration who were under age 30 or at least one islet autoantibody marker positive (GAD, IAA, or IA-2) at time of diagnosis or who currently are GAD or IA-2 autoantibody marker positive.

or

Normal control as defined by no family history of type 1 diabetes and normal tolerance test (tolerance testing to be performed as part of protocol).

Exclusion Criteria:

Individuals under 18 years of age
Individuals unable or unwilling to give informed consent/HIPAA authorization
Individuals who are clinically unstable
Individuals with any contraindications to MRI examination, for example, individuals with pacemakers
Pregnant or lactating women
Individuals with allergies to iron or dextran
Individuals with a history of cirrhosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585936

Contacts

Contact: Jason Gaglia, M.D.

617-264-2786

jason.gaglia@joslin.harvard.edu

Locations

United States, Massachusetts
Joslin Diabetes Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jason Gaglia, M.D. 617-264-2786 jason.gaglia@joslin.harvard.edu
Principal Investigator: Richard A Jackson, M.D.

Sponsors and Collaborators

Joslin Diabetes Center

Massachusetts General Hospital

AMAG Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Richard A Jackson, M.D.

Joslin Diabetes Center

More Information

Publications:

Turvey SE, Swart E, Denis MC, Mahmood U, Benoist C, Weissleder R, Mathis D. Noninvasive imaging of pancreatic inflammation and its reversal in type 1 diabetes. J Clin Invest. 2005 Sep;115(9):2454-61. Epub 2005 Aug 18.

Denis MC, Mahmood U, Benoist C, Mathis D, Weissleder R. Imaging inflammation of the pancreatic islets in type 1 diabetes. Proc Natl Acad Sci U S A. 2004 Aug 24;101(34):12634-9. Epub 2004 Aug 10.

Responsible Party:	Joslin Diabetes Center ( Richard Jackson )
Study ID Numbers:	Joslin 06-32, P01-A1-054904
Study First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00585936
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

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
Inflammation

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009