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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03585153




Registration number
NCT03585153
Ethics application status
Date submitted
18/06/2018
Date registered
12/07/2018
Date last updated
2/10/2024

Titles & IDs
Public title
Multicenter Assessment of the Pancreas in Type 1 Diabetes
Scientific title
Multicenter Assessment of the Pancreas in Type 1 Diabetes
Secondary ID [1] 0 0
3-SRA-2019-759-M-B
Secondary ID [2] 0 0
130883
Universal Trial Number (UTN)
Trial acronym
MAP-T1D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Non-contrast magnetic resonance imaging

T1D - Individuals with type 1 diabetes

Control - Individuals without type 1 diabetes

Aab+ - Individuals without type 1 diabetes who possess 2+ type 1 diabetes-related autoantibodies

MODY - Individuals with monogenic diabetes, or maturity-onset diabetes of the young (MODY)


Other interventions: Non-contrast magnetic resonance imaging
subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pancreas Volume Index
Timepoint [1] 0 0
Duration of subject's participation in the study
Secondary outcome [1] 0 0
MRI of pancreas - Apparent Diffusion Coefficient
Timepoint [1] 0 0
Duration of subject's participation in the study
Secondary outcome [2] 0 0
T1D Genetic Risk Score
Timepoint [2] 0 0
Once, at study enrollment
Secondary outcome [3] 0 0
T1D Autoantibodies
Timepoint [3] 0 0
Once, at study enrollment
Secondary outcome [4] 0 0
Urinary C-peptide/creatinine
Timepoint [4] 0 0
Once for controls, at study enrollment; Possibly at each visit for T1D

Eligibility
Key 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
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2050
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Institute of Medical Research - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
Vanderbilt University Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Texas at Austin
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Chicago
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Colorado, Denver
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
St Vincent's Institute of Medical Research
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Juvenile Diabetes Research Foundation
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03585153
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Alvin C. Powers, MD
Address 0 0
Vanderbilt University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03585153