Clinical trial NCT03585153: Multicenter Assessment of the Pancreas in Type 1 Diabetes
Official title: Multicenter Assessment of the Pancreas in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetes Mellitus
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: University of Chicago
name: University of Colorado, Denver
name: St Vincent's Institute of Medical Research
name: Juvenile Diabetes Research Foundation
First posted: 2018-07-12
Enrollment: 250
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Pancreas Volume Index
timeFrame: Duration of subject's participation in the study
Secondary outcomes:
measure: MRI of pancreas - Apparent Diffusion Coefficient
timeFrame: Duration of subject's participation in the study
measure: T1D Genetic Risk Score
timeFrame: Once, at study enrollment
measure: T1D Autoantibodies
timeFrame: Once, at study enrollment
measure: Urinary C-peptide/creatinine
timeFrame: Once for controls, at study enrollment; Possibly at each visit for T1D
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Barbara Davis Center
state: Colorado
city: Chicago
country: United States
facility: University of Chicago, Kovler Diabetes Center
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: University of Texas at Austin, Dell Medical School
state: Texas
city: Melbourne
country: Australia
facility: St. Vincent's Institute of Medical Research
state: Victoria
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alvin C. Powers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.