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Imaging Inflammation in Autoimmune Diabetes

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
AMAG Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00585936
First received: December 21, 2007
Last updated: November 9, 2011
Last verified: November 2011
  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

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

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 30
Study Start Date: September 2007
Study Completion Date: March 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
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:
Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00585936     History of Changes
Other Study ID Numbers: Joslin 06-32, P01-A1-054904
Study First Received: December 21, 2007
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014