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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

TypeOther DetailsAttachment
Informed consent form https://cdn.clinicaltrials.gov/large-docs/53/NCT03585153/ICF_000.pdf



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT03585153