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Imaging of Type 1 Diabetes Progression

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521520
First Posted: January 30, 2012
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Harvard Medical School
Information provided by (Responsible Party):
Jason Gaglia, Massachusetts General Hospital
January 26, 2012
January 30, 2012
April 10, 2017
January 2012
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Complete list of historical versions of study NCT01521520 on ClinicalTrials.gov Archive Site
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Imaging of Type 1 Diabetes Progression
Ferumoxytol Enhanced Magnetic Resonance Imaging of Type 1 Diabetes Progression
Type 1 diabetes results from the autoimmune destruction of the insulin-producing beta cells of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically silent with immune cells invading the pancreatic islets, a process termed insulitis, which eventually leads to loss of beta cells in the islets. If enough beta cells are destroyed, the body can not make enough insulin to maintain blood sugars in the normal range and clinical diabetes develops. The purpose of this study is to assess the ability of magnetic resonance imaging with ferumoxytol to detect changes in the pancreas associated with the insulitis of type 1 diabetes.

This study is designed to monitor changes associated with the development of autoimmune diabetes. A magnetic resonance imaging (MRI) based technique will be used to noninvasively measure changes within the pancreas associated with the development of autoimmune diabetes. The iron-containing drug ferumoxytol will be used as an intravenous MRI contrast agent for this study.

Individuals will be asked to participate one time, for 1-year, or over a 2-year period. During the development phase of the study, each imaging series will consist of 3 or more MRI scans. At the initial imaging visit a pre-ferumoxytol scan will be done, followed by ferumoxytol injection, and then an immediate post-injection scan. The subsequent scans will be concluded within 96 hours of ferumoxytol injection (typically at 48 hours). Those who participate for 1-year will have repeat imaging at approximate times 0, 6 months, and 12 months. Those who participate for 2-years will have repeat imaging at approximate times 0, 3, 6, 12, 18, and 24 months after enrollment.

Measurements of autoimmunity and metabolic parameters (collected as part of collaborating diabetes clinical studies) will be used in the data analysis for the longitudinal portion of the study. Stimulated C-peptide will be measured as a marker of endogenous insulin production capacity and beta-cell mass.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Non-Probability Sample
Study participants will be selected from those already participating in diabetes clinical trials.
Type 1 Diabetes
Drug: ferumoxytol
Ferumoxytol at a dose of between 1 and 6 mg iron/kg body weight (maximum 510 mg/injection) will be administered via intravenous injection. Ferumoxytol will be administered with each series of MRIs.
Other Name: Feraheme
  • Clinical Type 1 Diabetes
    This group will be subdivided into individuals with recent onset clinical type 1 diabetes (within 6 months of diagnosis), latent autoimmune diabetes of the adult, and longer standing type 1 diabetes.
    Intervention: Drug: ferumoxytol
  • High Risk Pre-Type 1 Diabetes
    High risk pre-type 1 diabetes is defined as first degree family relative with type 1 diabetes and at least one islet autoantibody marker (GAD, IAA, or IA-2).
    Intervention: Drug: ferumoxytol
  • Low Risk Pre-Type 1 Diabetes
    Low risk pre-type 1 diabetes is defined as first degree family relative with type 1 diabetes but no islet autoantibody markers (GAD, IAA, or IA-2).
    Intervention: Drug: ferumoxytol
  • Normal Control
    Normal control is based on history with no known history or family history of type 1 diabetes.
    Intervention: Drug: ferumoxytol
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 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
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Inclusion Criteria:

  • Participation in a collaborating diabetes clinical trial
  • Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures and are willing to participate

Exclusion Criteria:

  • Known allergy to ferumoxytol or iron
  • Individuals who are pregnant or lactating
  • Iron saturation above the upper limit of normal
  • Individuals with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)
  • Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01521520
2011P001957
P01AI054904 ( U.S. NIH Grant/Contract )
No
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Jason Gaglia, Massachusetts General Hospital
Jason Gaglia
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Harvard Medical School
Principal Investigator: Jason Gaglia, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2017