Imaging of Type 1 Diabetes Progression
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | January 2012 |
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.
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 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
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.
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 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
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.
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
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