ano-MRI to visualize pancreatic inflammation in individuals with recent-onset type 1 diabetes

Radboudumc0 sites25 target enrollmentAugust 7, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-Inclusion criteria (Individuals with type 1 diabetes):
•?Within 6 months of diagnosis with type 1 diabetes
•?Auto\-antibody positive
•\-Inclusion criteria (Control individuals):
•?No evidence of impaired glucose tolerance (HbA1c \< 42 mmol/mol (6%), fasting glucose \< 6\.1 mmol/L)
•\-Inclusion criteria (general):
•?Age \> 18 years
•Signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\-Contra\-indication to MRI scanning, iron infusion or hypersensitivity to the active substance or any of the excipients (like mentioned in the SPC).
•\- Known drug allergies or history of sever asthma, eczema or other ectopic allergies.
•\-Inability to lie still for at least 30 minutes or comply with imaging
•\-Hemochromatosis or liver disease defined as ALAT or ASAT level of more than three times the upper limit of normal range
•\-Renal dysfunction defined as MDRD \< 40 ml/min/1\.73m2
•\-Current pregnancy or the wish to become pregnant within 2 months
•\-Breast feeding
•\-Incapability to provide informed consent
•\-Pancreatitis
•\-Evidence of other inflammatory disease(s)