Visualizing beta cells after Intrahepatic Islet of Langerhans Transplantatio

Phase 2

Completed

Conditions: Transplantatie eilandjes van Langerhans
Intrahepatic islet transplantation in type 1 diabetes patients
10018424

Registration Number: NL-OMON47855

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 13

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

- 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 < 18 years
- No signed informed consent
- Exclusion criteria for MR:
* Metallic fragments, clips or devices in brain, eyes, spinal canal
* Implantable defibrillator or pacemaker (wires)
* Mandibular magnetic implants
* Neurostimulator, bladder stimulator, non-removable insulin pump
* Metal tissue-expander in chest
* Cochlear implant
* Ossicular replacement prosthesis

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameters of the study are the qualitative and quantitative<br /><br>assessment of the uptake of 68Ga-NODAGA-exendin-4 in the liver of T1D patients<br /><br>who received intrahepatic islet transplantation by PET/CT with additional<br /><br>MRI/MRS and compare this uptake to the uptake in the liver of healthy<br /><br>individuals.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The quantitative assessment of the detected signal in the liver compared to<br /><br>the functionality of the islet graft as assessed by clinical parameters.<br /><br>- The qualitative assessment of the distribution of uptake in the liver<br /><br>reflecting islet distribution across the liver.<br /><br>- Correlation between the distribution of uptake in the liver (PET) and<br /><br>structural abnormalities, such as hepatic steatosis (MRI/MRS)</p><br>