Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT03585153

Multicenter Assessment of the Pancreas in Type 1 Diabetes

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent's Institute of Medical Research, Melbourne, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Non-contrast magnetic resonance imaging

Other

subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

Primary outcomes

  1. Pancreas Volume Index

    Time frame: up to 10 years

    Size of the pancreas determined by longitudinal MRI, normalized to subject weight

Secondary outcomes

  1. MRI of pancreas - Apparent Diffusion Coefficient

    Time frame: up to 10 years

    MRI texture of pancreas

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Juvenile Diabetes Research Foundation
  • St Vincent's Institute of Medical Research
  • University of Chicago
  • University of Colorado, Denver
  • University of Texas at Austin

Registry information

Acronym: MAP-T1D

Important dates

Study start
2014
Primary completion
2028
Study completion
2050
First posted
Jul 12, 2018
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.