Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment ferumoxytol
Sponsor Jason Gaglia
Collaborator National Institute of Allergy and Infectious Diseases (NIAID)
Start date January 2012
Trial size 65 participants
Trial identifier NCT01521520, 2011P001957, P01AI054904

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
ferumoxytol Feraheme
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.
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).
ferumoxytol Feraheme
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.
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).
ferumoxytol Feraheme
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.
Normal control is based on history with no known history or family history of type 1 diabetes.
ferumoxytol Feraheme
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Ferumoxytol Enhanced Magnetic Resonance Imaging of Type 1 Diabetes Progression
Principal investigator Jason Gaglia, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.