Type 1 Diabetes Mellitus
Conditions
Brief summary
In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is performed to study the visualization of transplanted islet grafts in patients.
Detailed description
Detecting damage to islets with a reliable imaging technique could be important for improving islet survival after transplantation. This could lead to better patient outcomes which would be of great interest for the treatment of type 1 diabetes. In order to assess the possibility of visualizing transplanted islet grafts with Ga-68-NODAGA-exendin-4 PET, a proof-of -concept study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet transplantation with biochemically proven functional islet grafts and 5 patients with type 1 diabetes who are on the waiting list for islet transplantation. The investigators propose to determine the uptake of the radiolabeled tracer and compare it to functionality of the islet grafts. These highly relevant data will provide us with more information on the suitability of GLP-1 receptor imaging for monitoring of transplanted islet mass.
Interventions
RADIATION68Ga-NODAGA-exendin PET/CT
68Ga-NODAGA-exendin PET/CT
Sponsors
Radboud University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
Tx-group: * \>18 years old * T1D patient undergone islet transplantation * Clinically proven functional islet graft * Signed informed consent Control group: * \>18 years old * T1D patients who are on the waiting list for islet transplantation * Signed informed consent
Exclusion criteria
* Treatment with synthetic exendin or Dipeptidyl-Peptidase IV inhibitors within the last 3 months * Breast feeding * Pregnancy or the wish to become pregnant within 6 months * Kidney disease * Liver disease * Age \<18 years * No signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic uptake of 68Ga-NODAGA-exendin-4 | 1 year | Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Islet graft function | 1 year | Correlation of tracer uptake and islet graft function |
Countries
Netherlands, Sweden
Outcome results
None listed