MRI using small iron particles to look at inflammation in the pancreas of patients recently diagnosed with type 1 diabetes

Phase 1

• Conditions: Type 1 Diabetes; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001869-32-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-07
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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

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

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified