Multicenter Assessment of the Pancreas in Type 1 Diabetes

Diabetes Mellitus Clinical Trial

— MAP-T1D  

Official title:

Multicenter Assessment of the Pancreas in Type 1 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03585153
• Other study ID #: 130883
• Secondary ID: 3-SRA-2019-759-M
• Status: Enrolling by invitation
• Start date: February 19, 2014
• Est. completion date: June 2050

Study information

• Verified date: September 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: June 2050
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Non-contrast magnetic resonance imaging
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

Locations

Country	Name	City	State
Australia	St. Vincent's Institute of Medical Research	Melbourne	Victoria
United States	University of Colorado, Barbara Davis Center	Aurora	Colorado
United States	University of Texas at Austin, Dell Medical School	Austin	Texas
United States	University of Chicago, Kovler Diabetes Center	Chicago	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (6)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Juvenile Diabetes Research Foundation, St Vincent's Institute of Medical Research, University of Chicago, University of Colorado, Denver, University of Texas at Austin

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (2)

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 Fe — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreas Volume Index	Size of the pancreas determined by longitudinal MRI, normalized to subject weight	Duration of subject's participation in the study
Secondary	MRI of pancreas - Apparent Diffusion Coefficient	MRI texture of pancreas	Duration of subject's participation in the study
Secondary	T1D Genetic Risk Score	Saliva will be collected and used to make DNA to determine a T1D genetic risk score	Once, at study enrollment
Secondary	T1D Autoantibodies	Control subjects who enroll will be asked to have their blood drawn to determine their T1D autoantibody status	Once, at study enrollment
Secondary	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