Multicenter Assessment of the Pancreas in Type 1 Diabetes

Last updated: September 30, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Enrolling

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Non-contrast magnetic resonance imaging

Clinical Study ID

NCT03585153
130883
3-SRA-2019-759-M-B
3-SRA-2015-102-M-B
  • Ages > 8
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Subjects with pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, orneuroendocrine tumors

  • Subjects who have any type of bioimplant activated by mechanical, electronic, ormagnetic means because such devices may be displaced or malfunction

  • Subjects who have any type of ferromagnetic bioimplant that could potentially bedisplaced

  • Subjects who are pregnant or breast-feeding. Urine pregnancy test will be performedon women of child bearing potential who are not practicing appropriate contraceptionmeasures 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 Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Non-contrast magnetic resonance imaging
Phase:
Study Start date:
February 19, 2014
Estimated Completion Date:
June 30, 2050

Study 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.

Connect with a study center

  • St. Vincent's Institute of Medical Research

    Melbourne, Victoria
    Australia

    Site Not Available

  • University of Colorado, Barbara Davis Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Chicago, Kovler Diabetes Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • University of Texas at Austin, Dell Medical School

    Austin, Texas 78712
    United States

    Site Not Available

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