Type 1 Diabetes
Conditions
Interventions
Product Name: Ferrotran
Product Code: Ferrotran
Pharmaceutical Form: Infusion
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion 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 18 years Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare pancreatic macrophage infiltration between individuals with T1D and controls by imaging intracellular iron particle accumulation in macrophages by late-phase MR imaging. To achieve this we will first develop an optimized nano-MRI protocol in 5 healthy volunteers.;Secondary Objective: • Compare pancreatic perfusion between individuals with T1D and non-diabetic control individuals by MR imaging of the angiographic phase after iron particle contrast infusion (comparing baseline perfusion and perfusion upon stimulation of pancreatic islets by glucose). • Compare nano-MRI with quantitative dynamic [18F]FDG PET/CT to cross-validate the potential of nano-MRI to determine pancreatic inflammation. • Correlate pancreatic macrophage infiltration to (residual) beta cell function assessed by oral glucose tolerance test and arginine stimulation. ;Primary end point(s): The main parameter of the study is the comparison of macrophage infiltration between individuals with T1D and controls. ;Timepoint(s) of evaluation of this end point: After inclusion of all patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Comparison of pancreatic perfusion between individuals with T1D and controls o Comparison of nano-MRI with [18F]FDG PET/CT for cross-validation of the potential of nano-MRI to determine pancreatic inflammation o Correlation of pancreatic macrophage infiltration to (residual) beta cell function ;Timepoint(s) of evaluation of this end point: After inclusion of all patients | — |
Countries
Netherlands
Contacts
Public ContactRadboudumc Nuclear Medicine
Radboudumc
Outcome results
None listed