Type 1 Diabetes MellitusGLP1-transplNCT03785236
Visualizing Beta Cells After Islet Transplantation
An observational study of Type 1 Diabetes Mellitus, run by Radboud University Medical Center at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- 68Ga-NODAGA-exendin PET/CT
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2016to 27 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The population consists of 10 individuals with type 1 diabetes patients who have undergone intrahepatic islet transplantation at least 3 months earlier at. Furthermore, 5 T1D patients without an islet transplant will be included as a control for uptake of the radiotracer in the liver. All participating individuals need to be 18 years or older. In total, 15 participants will be included.
Who may be able to join
- Tx-group:
- >18 years old
- T1D patient undergone islet transplantation
- Clinically proven functional islet graft
- Signed informed consent
- Control group:
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- >18 years old
- T1D patients who are on the waiting list for islet transplantation
- Signed informed consent
Who cannot join
- 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
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- No signed informed consent
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
Official title: Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- 68Ga-NODAGA-exendin PET/CT
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-exendin PET/CTRadiation
68Ga-NODAGA-exendin PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Tx-group | T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier Receives: Radiation: 68Ga-NODAGA-exendin PET/CT | |
| Control group | T1D patients that await islet of Langerhans transplantation Receives: Radiation: 68Ga-NODAGA-exendin PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic uptake of 68Ga-NODAGA-exendin-4
Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis
Measured: 1 year
Secondary outcomes (1)
Islet graft function
Correlation of tracer uptake and islet graft function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start6 Jun 2016
- Primary completion27 May 2021
- Study completion27 May 2021
Why it stopped: Suitable participants have complicated T1D, often with serious complications, participation is therefore challenging. Participants also fall within an unique group and few suitable individuals were available for inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785236
- Sponsor's protocol ID
- NL52630.091.15
- Acronym
- GLP1-transpl
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2018
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation
- ClinicalTrials.gov ID
- NCT03785236
- Acronym / sponsor ID
- GLP1-transpl / NL52630.091.15
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Suitable participants have complicated T1D, often with serious complications, participation is therefore challenging. Participants also fall within an unique group and few suitable individuals were available for inclusion.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tx-group | – | Radiation: 68Ga-NODAGA-exendin PET/CTT1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier |
| Control group | – | Radiation: 68Ga-NODAGA-exendin PET/CTT1D patients that await islet of Langerhans transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population consists of 10 individuals with type 1 diabetes patients who have undergone intrahepatic islet transplantation at least 3 months earlier at. Furthermore, 5 T1D patients without an islet transplant will be included as a control for uptake of the radiotracer in the liver. All participating individuals need to be 18 years or older. In total, 15 participants will be included.
Key inclusion criteria (9 listed)
- >18 years old
- T1D patient undergone islet transplantation
- Clinically proven functional islet graft
- Signed informed consent
- >18 years old
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-exendin PET/CT68Ga-NODAGA-exendin PET/CT | Radiation | Control group, Tx-group |
Primary outcome
Hepatic uptake of 68Ga-NODAGA-exendin-4
Time frame: 1 year
Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis
1 secondary outcome
Islet graft function
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Suitable participants have complicated T1D, often with serious complications, participation is therefore challenging. Participants also fall within an unique group and few suitable individuals were available for inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Radboud University Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Suitable participants have complicated T1D, often with serious complications, participation is therefore challenging. Participants also fall within an unique group and few suitable individuals were available for inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic uptake of 68Ga-NODAGA-exendin-4 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.