Multicenter Assessment of the Pancreas in Type 1 Diabetes

NCT ID: NCT03585153

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-19
• Study Completion Date: 2050-12-31

Brief 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.

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

Study Design

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

Study Groups

Individuals with stage 3 T1D

Individuals with overt stage 3 type 1 diabetes

Non-contrast magnetic resonance imaging

Intervention Type: OTHER

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

Healthy control

Individuals without type 1 diabetes

Non-contrast magnetic resonance imaging

Intervention Type: OTHER

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

Autoantibody positive

Individuals with early stage type 1 diabetes (stage 1, stage 2) who possess two or more type 1 diabetes-related autoantibodies

Non-contrast magnetic resonance imaging

Intervention Type: OTHER

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

Monogenic diabetes

Individuals with monogenic diabetes

Non-contrast magnetic resonance imaging

Intervention Type: OTHER

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

Interventions

Non-contrast magnetic resonance imaging

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

St Vincent's Institute of Medical Research

OTHER

Sponsor Role: collaborator

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel Moore

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alvin C. Powers, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

University of Colorado, Barbara Davis Center

Aurora, Colorado, United States

University of Chicago, Kovler Diabetes Center

Chicago, Illinois, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas at Austin, Dell Medical School

Austin, Texas, United States

St. Vincent's Institute of Medical Research

Melbourne, Victoria, Australia

Countries

United States; Australia

References

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.

Reference Type: RESULT

PMID: 30552135 (View on PubMed)

Williams 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.

Reference Type: RESULT

PMID: 32179809 (View on PubMed)

Wright 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.

Reference Type: DERIVED

PMID: 36938587 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

3-SRA-2019-759-M-B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

3-SRA-2015-102-M-B

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

130883

Identifier Type: -

Identifier Source: org_study_id