Transplantatie eilandjes van Langerhans Intrahepatic islet transplantation in type 1 diabetes patients
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: - > 18 years old - T1D patient undergone islet transplantation - Clinically proven functional islet graft (stimulated C-peptide > 0.8 nmol/L) - Signed informed consent Inclusion criteria T1D patients without an islet transplant - > 18 years old - Signed informed consent;on the waiting list for islet transplantation
Exclusion criteria
Exclusion criteria: - Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors within the last 3 months - Breast feeding - Pregnancy or the wish to become pregnant within 6 months - Affected kidney function * Calculated creatinine clearance below 30ml/min - Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range (45 U/L). - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameters of the study are the qualitative and quantitative assessment of the uptake of 68Ga-NODAGA-exendin-4 in the liver of T1D patients who received intrahepatic islet transplantation by PET/CT with additional MRI/MRS and compare this uptake to the uptake in the liver of healthy individuals. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The quantitative assessment of the detected signal in the liver compared to the functionality of the islet graft as assessed by clinical parameters. - The qualitative assessment of the distribution of uptake in the liver reflecting islet distribution across the liver. - Correlation between the distribution of uptake in the liver (PET) and structural abnormalities, such as hepatic steatosis (MRI/MRS) | — |
Countries
Netherlands
Outcome results
None listed