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

Withdrawn

Conditions: Diabetes Mellitus type 1
Type 1 diabetes
10003816

Registration Number: NL-OMON48407

Lead Sponsor: ucleaire geneeskunde en radiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 25

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
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/1.73m^2
- 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in iron particle accumulation in<br /><br>macrophages between individuals with T1D and control individuals as a measure<br /><br>for pancreatic macrophage infiltration.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o Comparison of pancreatic perfusion between individuals with T1D and controls<br /><br>o Comparison of nano-MRI with [18F]FDG PET/CT for cross-validation of the<br /><br>potential of nano-MRI to determine pancreatic inflammation<br /><br>o Correlation of pancreatic macrophage infiltration to (residual) beta cell<br /><br>function</p><br>