Diabetes MellitusMAP-T1DNCT03585153
Multicenter Assessment of the Pancreas in Type 1 Diabetes
An observational study of Diabetes Mellitus, run by Vanderbilt University Medical Center at 5 sites in 2 countries.
Trial summary
The overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative magnetic resonance imaging (MRI) approaches. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Non-contrast magnetic resonance imaging
- How many people
- 250 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Feb 2014to Dec 2050
- Phase
- Observational
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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals with diabetes for this study may be referred by any pediatric or adult endocrinologists. Healthy controls are recruited via a passive recruitment process. A small subset of controls will travel to multiple study centers to have an MRI. In this study, the MRI scan will be used for research purposes only. However, if we see something that is not normal, the participant will be told and asked to consult his or her doctor.
Who may be able to join
- Subjects at least 8 years of age
- Subjects with T1D must be imaged within 100 days of their date of diagnosis
- Subjects must be able to read and provide assent/informed written consent
Who cannot join
- Subjects with pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumors
- Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means because such devices may be displaced or malfunction
- Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
- Subjects who are pregnant or breast-feeding. Urine pregnancy test will be performed on women of child bearing potential who are not practicing appropriate contraception measures or menstruating.
- Subjects who exhibit significant anxiety and/or claustrophobia
- Subjects incapable of giving assent/informed written consent
- For controls: subjects who have first degree relatives with T1D
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites
University of Colorado, Barbara Davis Center
Aurora, Colorado, 80045
University of Texas at Austin, Dell Medical School
Austin, Texas, 78712
University of Chicago, Kovler Diabetes Center
Chicago, Illinois, 60637
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Australia1 site
St. Vincent's Institute of Medical Research
Melbourne, Victoria
About this study
The overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative magnetic resonance imaging (MRI) approaches.
Read the detailed description
This research applies magnetic resonance imaging (MRI) techniques to study the pancreas of individuals with type 1 diabetes (T1D) and other forms of diabetes. Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults, and in non-diabetic individuals expressing islet autoantibodies that portend the development of T1D. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas. These unexpected findings raise fundamental questions that challenge our understanding of T1D pathogenesis. These changes in pancreatic volume and size before and soon after onset of T1D, as detected by MRI, appear to be a marker of the T1D pathogenic disease process. There is an urgent need to determine whether similar observations can be obtained at different centers using different MRI platforms. Discovery of unknown changes may lead to new ways to treat disease. The MRI techniques may also be useful for following how T1D is progressing in different people, determining whether new drugs are effective, and ultimately detecting T1D in people earlier than currently possible.
- Conditions
- Diabetes Mellitus
- Being tested
- Non-contrast magnetic resonance imaging
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast magnetic resonance imagingOther
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas
| Study group | Role | What they receive |
|---|---|---|
| Individuals with stage 3 T1D | Individuals with overt stage 3 type 1 diabetes Receives: Other: Non-contrast magnetic resonance imaging | |
| Healthy control | Individuals without type 1 diabetes Receives: Other: Non-contrast magnetic resonance imaging | |
| Autoantibody positive | Individuals with early stage type 1 diabetes (stage 1, stage 2) who possess two or more type 1 diabetes-related autoantibodies Receives: Other: Non-contrast magnetic resonance imaging | |
| Monogenic diabetes | Individuals with monogenic diabetes Receives: Other: Non-contrast magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreas Volume Index
Size of the pancreas determined by longitudinal MRI, normalized to subject weight
Measured: up to 10 years
Secondary outcomes (1)
MRI of pancreas - Apparent Diffusion Coefficient
MRI texture of pancreas
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start19 Feb 2014
- Primary completionDec 2028 (estimated)
- Study completionDec 2050 (estimated)
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 MellitusStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin, University of Chicago, University of Colorado, Denver, St Vincent's Institute of Medical Research, Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Daniel Moore, Vanderbilt University Medical Center
- Investigators
- Alvin C. Powers, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585153
- Sponsor's protocol ID
- 130883
- Other IDs
- 3-SRA-2019-759-M-B, 3-SRA-2015-102-M-B
- Acronym
- MAP-T1D
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2018
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virostko J, Williams J, Hilmes M, Bowman C, Wright JJ, Du L, Kang H, Russell WE, Powers AC, Moore DJ. Pancreas Volume Declines During the First Year After Diagnosis of Type 1 Diabetes and Exhibits Altered Diffusion at Disease Onset. Diabetes Care. 2019 Feb;42(2):248-257. doi: 10.2337/dc18-1507. Epub 2018 Dec 14.
PubMed 30552135Williams JM, Hilmes MA, Archer B, Dulaney A, Du L, Kang H, Russell WE, Powers AC, Moore DJ, Virostko J. Repeatability and Reproducibility of Pancreas Volume Measurements Using MRI. Sci Rep. 2020 Mar 16;10(1):4767. doi: 10.1038/s41598-020-61759-9.
PubMed 32179809Wright JJ, Dulaney A, Williams JM, Hilmes MA, Du L, Kang H, Powers AC, Moore DJ, Virostko J. Longitudinal MRI Shows Progressive Decline in Pancreas Size and Altered Pancreas Shape in Type 1 Diabetes. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2699-2707. doi: 10.1210/clinem/dgad150.
PubMed 36938587