Imaging Inflammation in Autoimmune Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Evaluation of Magnetic Nanoparticle Enhanced Imaging in Autoimmune Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585936
• Other study ID #: Joslin 06-32
• Secondary ID: P01-A1-054904
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: November 9, 2011
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: November 2011
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	AMAG Pharmaceuticals, Inc., Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Gaglia JL, Guimaraes AR, Harisinghani M, Turvey SE, Jackson R, Benoist C, Mathis D, Weissleder R. Noninvasive imaging of pancreatic islet inflammation in type 1A diabetes patients. J Clin Invest. 2011 Jan;121(1):442-5. doi: 10.1172/JCI44339. Epub 2010 Dec — View Citation

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. — View Citation