NL-OMON48407
Withdrawn
Not Applicable
ano-MRI to visualize pancreatic inflammation in individuals with recent-onset type 1 diabetes - Nano-PRIDE
ucleaire geneeskunde en radiologie0 sites25 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ucleaire geneeskunde en radiologie
- Enrollment
- 25
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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 severe asthma, eczema or other ectopic
- •\- 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\.73m^2
- •\- Current pregnancy or the wish to become pregnant within 2 months
- •\- Breast feeding
- •\- Incapability to provide informed consent
Outcomes
Primary Outcomes
Not specified
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