Multicenter Assessment of the Pancreas in Type 1 Diabetes

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
MODY	Non-contrast magnetic resonance imaging	Individuals with monogenic diabetes, or maturity-onset diabetes of the young (MODY)
T1D	Non-contrast magnetic resonance imaging	Individuals with type 1 diabetes
Control	Non-contrast magnetic resonance imaging	Individuals without type 1 diabetes
Aab+	Non-contrast magnetic resonance imaging	Individuals without type 1 diabetes who possess 2+ type 1 diabetes-related autoantibodies

Primary Outcome Measures

Name	Time	Method
Pancreas Volume Index	Duration of subject's participation in the study	Size of the pancreas determined by longitudinal MRI, normalized to subject weight

Secondary Outcome Measures

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

Locations (5): St. Vincent's Institute of Medical Research
🇦🇺
Melbourne, Victoria, Australia
University of Colorado, Barbara Davis Center
🇺🇸
Aurora, Colorado, United States
University of Chicago, Kovler Diabetes Center
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Chicago, Illinois, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
University of Texas at Austin, Dell Medical School
🇺🇸
Austin, Texas, United States