Imaging of Type 1 Diabetes Progression

NCT ID: NCT01521520

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31

Brief 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.

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, 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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ferumoxytol

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Normal control is based on history with no known history or family history of type 1 diabetes.

ferumoxytol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Feraheme

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Jason Gaglia

OTHER

Sponsor Role: lead

Responsible Party

Jason Gaglia

Research Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jason Gaglia, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21123946 (View on PubMed)

Other Identifiers

P01AI054904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011P001957

Identifier Type: -

Identifier Source: org_study_id