Type 1 Diabetes Mellitus
Conditions
Keywords
islet transplantation, magnetic resonance, Type 1 DM
Brief summary
The purpose of the study is to determine whether human islets labeled by iron contrast agents could be imaged using magnetic resonance after transplantation into the liver of Type 1 diabetic recipients.
Detailed description
Islet transplantation represents approved therapeutic approach in selected Type 1 diabetic recipients with syndrome of hypoglycaemia unawareness. Existing imaging methods are not sufficient to provide adequate information about amount and fate of islets transplanted into the liver. Labeling of islets with superparamagnetic contrast agent ferucarbotran significantly shortens T2 relaxing time and therefore increase the contrast between islets and liver tissue in magnetic resonance imaging. In consequence, islets transplanted into liver could be easily detectable like hypotensive areas dispersed throughout the liver. MRI examination will be done on 1, 2, 4 weeks and 3, 6 and 12 months.
Interventions
OTHERTransplantation of labeled islets
Sponsors
Frantisek Saudek
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus * normal renal parameters * hypoglycaemia unawareness or rapid progression of diabetic retinopathy or neuropathy
Exclusion criteria
* acute and chronic liver disease * malignancy * acute infection * serious cardiovascular disease * coagulopathy * portal hypertension * presence of metal protesis, cardio-stimulators, or other metal material in the body
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets | 1 year |
Countries
Czechia
Outcome results
None listed