Imaging of Type 1 Diabetes Progression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Harvard Medical School
Information provided by (Responsible Party):
Jason Gaglia, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01521520
First received: January 26, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Drug: ferumoxytol

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ferumoxytol Enhanced Magnetic Resonance Imaging of Type 1 Diabetes Progression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 65
Study Start Date: January 2012
Groups/Cohorts Assigned Interventions
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.
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
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).
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
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).
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
Normal Control
Normal control is based on history with no known history or family history of 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

Detailed 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.

  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

Study participants will be selected from those already participating in diabetes clinical trials.

Criteria

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
  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: NCT01521520

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Jason Gaglia
Harvard Medical School
Investigators
Principal Investigator: Jason Gaglia, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Jason Gaglia, Research Scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01521520     History of Changes
Other Study ID Numbers: 2011P001957, P01AI054904
Study First Received: January 26, 2012
Last Updated: July 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
type 1 diabetes
magnetic resonance imaging
insulitis
ferumoxytol

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Parenteral Nutrition Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 16, 2014