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

Radboudumc0 个研究点目标入组 25 人开始时间: 2019年8月7日最近更新: 2020年6月22日

适应症

试验速览

暂无简介。

•-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

•-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)

发起方