Multicenter Assessment of the Pancreas in Type 1 Diabetes (MAP-T1D)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Non-contrast magnetic resonance imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • St. Vincent's Institute of Medical Research
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado, Barbara Davis Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago, Kovler Diabetes Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin, Dell Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T1D; Individuals with type 1 diabetes	Other: Non-contrast magnetic resonance imaging; subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas
Control; Individuals without type 1 diabetes	Other: Non-contrast magnetic resonance imaging; subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas
Aab+; Individuals without type 1 diabetes who possess 2+ type 1 diabetes-related autoantibodies	Other: Non-contrast magnetic resonance imaging; subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas
MODY; Individuals with monogenic diabetes, or maturity-onset diabetes of the young (MODY)	Other: Non-contrast magnetic resonance imaging; subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreas Volume Index	Size of the pancreas determined by longitudinal MRI, normalized to subject weight	Duration of subject's participation in the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI of pancreas - Apparent Diffusion Coefficient	MRI texture of pancreas	Duration of subject's participation in the study
T1D Genetic Risk Score	Saliva will be collected and used to make DNA to determine a T1D genetic risk score	Once, at study enrollment
T1D Autoantibodies	Control subjects who enroll will be asked to have their blood drawn to determine their T1D autoantibody status	Once, at study enrollment
Urinary C-peptide/creatinine	Urine may be collected on all participants to assess urinary C-peptide/creatinine ratio	Once for controls, at study enrollment; Possibly at each visit for T1D

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: University of Colorado, Denver; Juvenile Diabetes Research Foundation; University of Chicago; University of Texas at Austin; St Vincent's Institute of Medical Research
• Investigators: Principal Investigator: Alvin C. Powers, MD, Vanderbilt University Medical Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2014
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2050

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 30, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 130883; 3-SRA-2019-759-M-B (Other Grant/Funding Number: JDRF); 3-SRA-2015-102-M-B (Other Grant/Funding Number: JDRF)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No