Visualizing Beta Cells After Islet Transplantation

Type 1 Diabetes Mellitus Clinical Trial

— GLP1-transpl  

Official title:

Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03785236
• Other study ID #: NL52630.091.15
• Status: Terminated
• Start date: June 6, 2016
• Est. completion date: May 27, 2021

Study information

• Verified date: January 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion criteria for MR:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Radiation:
• 68Ga-NODAGA-exendin PET/CT
68Ga-NODAGA-exendin PET/CT

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic uptake of 68Ga-NODAGA-exendin-4	Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis	1 year
Secondary	Islet graft function	Correlation of tracer uptake and islet graft function	1 year