Diabetes Mellitus, Type 1NCT00585936
Imaging Inflammation in Autoimmune Diabetes
An observational study of Diabetes Mellitus, Type 1, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether magnetic resonance imaging (MRI) with ferumoxtran-10 can be used to detect changes in the pancreas associated with autoimmune diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is to be drawn from the general population, diabetes clinic population, and at risk individuals as previously identified in prior family studies.
Who may be able to join
- Recent onset type 1 diabetes as defined by clinical diagnosis within the last 6 months and age less than 30 or at least one islet autoantibody marker (GAD, IAA, or IA-2).
- or
- High risk of pre-type 1 diabetes as defined by first degree family relative with type 1 diabetes and at least one islet autoantibody marker (GAD, IAA, or IA-2).
- or
- Individuals with established type 1 diabetes of greater than 6 months duration who were under age 30 or at least one islet autoantibody marker positive (GAD, IAA, or IA-2) at time of diagnosis or who currently are GAD or IA-2 autoantibody marker positive.
- or
- Normal control as defined by no family history of type 1 diabetes and normal tolerance test (tolerance testing to be performed as part of protocol).
Who cannot join
- Individuals under 18 years of age
- Individuals unable or unwilling to give informed consent/HIPAA authorization
- Individuals who are clinically unstable
- Individuals with any contraindications to MRI examination, for example, individuals with pacemakers
- Pregnant or lactating women
- Individuals with allergies to iron or dextran
- Individuals with a history of cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Magnetic Nanoparticle Enhanced Imaging in Autoimmune Diabetes
The purpose of this study is to determine whether magnetic resonance imaging (MRI) with ferumoxtran-10 can be used to detect changes in the pancreas associated with autoimmune diabetes.
Read the detailed description
Approximately one million individuals are afflicted with autoimmune Type 1 diabetes mellitus (T1DM) in the United States. This disease results from the autoimmune destruction of the insulin-producing beta-cells of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically occult with localized pancreatic inflammation characterized by a lymphocytic infiltration of the pancreatic islets, termed insulitis, which leads to beta-cell specific destruction of the islets. This is often followed by the clinically overt phase that ensues when the bulk of beta cells have been destroyed and the pancreas is no longer able to produce sufficient insulin to maintain glycemic control. The purpose of this study is to assess the ability of magnetic resonance imaging with ferumoxtran-10, a functional molecular imaging agent consisting of iron oxide nanoparticles, to detect changes in the pancreas associated with the insulitis of T1DM.
- Conditions
- Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal controls without evidence of diabetes or islet specific autoimmunity | |
| 2 | Individuals within 6 months of diagnosis with type 1 diabetes | |
| 3 | Individuals at high risk for the development of type 1 diabetes | |
| 4 | Individuals with longstanding autoimmune diabetes |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard A Jackson, M.D., Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585936
- Sponsor's protocol ID
- Joslin 06-32
- Other IDs
- P01-A1-054904
- Status last verified
- Nov 2011
- First submitted
- 21 Dec 2007
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turvey SE, Swart E, Denis MC, Mahmood U, Benoist C, Weissleder R, Mathis D. Noninvasive imaging of pancreatic inflammation and its reversal in type 1 diabetes. J Clin Invest. 2005 Sep;115(9):2454-61. doi: 10.1172/JCI25048. Epub 2005 Aug 18.
PubMed 16110329Denis MC, Mahmood U, Benoist C, Mathis D, Weissleder R. Imaging inflammation of the pancreatic islets in type 1 diabetes. Proc Natl Acad Sci U S A. 2004 Aug 24;101(34):12634-9. doi: 10.1073/pnas.0404307101. Epub 2004 Aug 10.
PubMed 15304647Gaglia 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.
PubMed 21123946
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Magnetic Nanoparticle Enhanced Imaging in Autoimmune Diabetes
- ClinicalTrials.gov ID
- NCT00585936
- Acronym / sponsor ID
- Joslin 06-32
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, AMAG Pharmaceuticals, Inc.
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether magnetic resonance imaging (MRI) with ferumoxtran-10 can be used to detect changes in the pancreas associated with autoimmune diabetes.
Detailed description
Approximately one million individuals are afflicted with autoimmune Type 1 diabetes mellitus (T1DM) in the United States. This disease results from the autoimmune destruction of the insulin-producing beta-cells of the islets of Langerhans of the pancreas. Initially, diabetes is usually clinically occult with localized pancreatic inflammation characterized by a lymphocytic infiltration of the pancreatic islets, termed insulitis, which leads to beta-cell specific destruction of the islets. This is often followed by the clinically overt phase that ensues when the bulk of beta cells have been destroyed and the pancreas is no longer able to produce sufficient insulin to maintain glycemic control. The purpose of this study is to assess the ability of magnetic resonance imaging with ferumoxtran-10, a functional molecular imaging agent consisting of iron oxide nanoparticles, to detect changes in the pancreas associated with the insulitis of T1DM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Normal controls without evidence of diabetes or islet specific autoimmunity |
| 2 | – | –Individuals within 6 months of diagnosis with type 1 diabetes |
| 3 | – | –Individuals at high risk for the development of type 1 diabetes |
| 4 | – | –Individuals with longstanding autoimmune diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is to be drawn from the general population, diabetes clinic population, and at risk individuals as previously identified in prior family studies.
Key inclusion criteria (7 listed)
- Recent onset type 1 diabetes as defined by clinical diagnosis within the last 6 months and age less than 30 or at least one islet autoantibody marker (GAD, IAA, or IA-2).
- or
- High risk of pre-type 1 diabetes as defined by first degree family relative with type 1 diabetes and at least one islet autoantibody marker (GAD, IAA, or IA-2).
- or
- Individuals with established type 1 diabetes of greater than 6 months duration who were under age 30 or at least one islet autoantibody marker positive (GAD, IAA, or IA-2) at time of diagnosis or who currently are GAD or IA-2 autoantibody marker positive.
Key exclusion criteria (7 listed)
- Individuals under 18 years of age
- Individuals unable or unwilling to give informed consent/HIPAA authorization
- Individuals who are clinically unstable
- Individuals with any contraindications to MRI examination, for example, individuals with pacemakers
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
- Background: PubMed 16110329Turvey SE, Swart E, Denis MC, Mahmood U, Benoist C, Weissleder R, Mathis D. Noninvasive imaging of pancreatic inflammation and its reversal in type 1 diabetes. J Clin Invest. 2005 Sep;115(9):2454-61. doi: 10.1172/JCI25048. Epub 2005 Aug 18.
- Background: PubMed 15304647Denis MC, Mahmood U, Benoist C, Mathis D, Weissleder R. Imaging inflammation of the pancreatic islets in type 1 diabetes. Proc Natl Acad Sci U S A. 2004 Aug 24;101(34):12634-9. doi: 10.1073/pnas.0404307101. Epub 2004 Aug 10.
- Results publication: PubMed 21123946Gaglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Jackson, M.D. principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2011.