Imaging of Type 1 Diabetes Progression

NCT01521520 | Unknown

• 2 other identifiers: 2011P001957P01AI054904
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; magnetic resonance imaging; insulitis; ferumoxytol

Study Arms (4)

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

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

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

Normal Control

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

Drug: ferumoxytol

Interventions

ferumoxytol 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.

Also known as: Feraheme

Clinical Type 1 Diabetes; High Risk Pre-Type 1 Diabetes; Low Risk Pre-Type 1 Diabetes; Normal Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Gaglia: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 21123946 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Jason Gaglia, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)