Islets of Langerhans TransplantationALADDINNCT05540197
Arginine-stimulated Indication of Early Outcome After Islet Transplantation
An observational study of Islets of Langerhans Transplantation and Diabetes Mellitus, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Through islet transplantation, functional β-cell mass can be restored. Allogeneic islet transplantation is a treatment modality for a select group of patients with complicated type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Islets of Langerhans Transplantation, Diabetes Mellitus, Chronic Pancreatitis
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Feb 2023to Oct 2025
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving allogeneic or autologous islet transplants.
Who may be able to join
- Age 16 years or older
- Currently on the LUMC waiting list for allogeneic or autologous islet transplantation
- Willing to use a flash glucose monitoring (FGM) system in the two weeks prior to transplantation
Who cannot join
- Patients who are pregnant
- Patients with known hypersensitivity to arginine
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
Through islet transplantation, functional β-cell mass can be restored. Allogeneic islet transplantation is a treatment modality for a select group of patients with complicated type 1 diabetes mellitus. For patients undergoing (partial) pancreas resection, autologous islet transplantation may help prevent complicated diabetes. Up until now, no studies have been performed on early islet graft function in the first week after transplantation. Early graft function may be a predictor for estimating long-term islet graft success.
Arginine can excite β-cells to release insulin. It can thus provide an estimate of β-cell secretory capacity and can be used as an alternative to (oral) glucose tolerance tests. In this study, we aim to find a predictor model for islet graft function by assessing peak C-peptide after arginine stimulus in the early post-transplantation phase.
- Keywords
- total pancreatectomy, autologous islet transplantation, TPIAT, beta-cell function, c-peptide, arginine, mixed meal tolerance test, allogeneic islet transplantation, islet function, ibmir
- Medical subject headings
- Diabetes Mellitus, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autologous islet transplantation | Arginine stimulation test: 5 grams of arginine hydrochloride intravenously. Performed at baseline after mixed meal tolerance test (MMTT), performed separately at day -1 or 0, day 1, day 3, day 7 and 3 months, and also at 3 months after MMTT. | |
| Allogeneic islet transplantation | Arginine stimulation test: 5 grams of arginine hydrochloride intravenously. Performed at day -1 or 0, day 1, day 3, day 7, 3 months and at 3 months after MMTT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early islet graft function
Peak C-peptide during AST at day 3
Measured: Day 3
Early islet graft function
AUC C-peptide during MMTT at 3 months
Measured: Month 3
Secondary outcomes (17)
Early islet graft function
Peak C-peptide during AST and MMTT (other than primary)
Measured: Up to 3 months
Early islet graft function
AUC C-peptide during AST and MMTT (other than primary)
Measured: Up to 3 months
Insulin secretory capacity
Relationship between in vitro secretion and in vivo secretion
Measured: Up to 3 months
Beta-cell death
Circulating free INS DNA (INS cfDNA)
Measured: Up to 3 months
Beta-cell death
insulin - proinsulin ratio
Measured: Up to 3 months
Beta-cell death
Plasma circulating microRNA
Measured: Up to 3 months
Complement factors
Markers of complement activation
Measured: Up to 3 months
Immunological markers
Peripheral blood mononuclear cell (PBMC) composition
Measured: Up to 3 months
Immunological markers
T-cell phenotyping
Measured: Up to 3 months
Beta cell graft function
Time in range, time below range, time above range as measured by Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM)
Measured: Up to 3 months
Beta cell graft function
assessed by Igls 2.0 criteria
Measured: 3 months
Treatment success
assessed by Igls 2.0 criteria
Measured: 3 months
Beta cell graft function
Amount of severe hypoglycaemic events
Measured: Up to 3 months
Beta cell graft function
Insulin requirements (IU/kg/day)
Measured: Up to 3 months
Glycemic control
HbA1c (mmol/mol)
Measured: Up to 3 months
Coagulation markers
Markers indicative for activation of the coagulation cascade
Measured: Up to 3 months
Insulin concentration
Concentration of insulin in the islet product
Measured: Before the islet transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start23 Feb 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Islets of Langerhans TransplantationStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eelco JP de Koning, Leiden University Medical Center
- Investigators
- Prof. Eelco de Koning, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540197
- Sponsor's protocol ID
- NL79536.058.22
- Acronym
- ALADDIN
- Status last verified
- Jun 2024
- First submitted
- 9 Sep 2022
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine-stimulated Indication of Early Outcome After Islet Transplantation
- ClinicalTrials.gov ID
- NCT05540197
- Acronym / sponsor ID
- ALADDIN / NL79536.058.22
- Keywords
- total pancreatectomy, autologous islet transplantation, TPIAT, beta-cell function, c-peptide, arginine, mixed meal tolerance test, allogeneic islet transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Sep 2022 (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.
Through islet transplantation, functional β-cell mass can be restored. Allogeneic islet transplantation is a treatment modality for a select group of patients with complicated type 1 diabetes mellitus. For patients undergoing (partial) pancreas resection, autologous islet transplantation may help prevent complicated diabetes. Up until now, no studies have been performed on early islet graft function in the first week after transplantation. Early graft function may be a predictor for estimating long-term islet graft success.
Arginine can excite β-cells to release insulin. It can thus provide an estimate of β-cell secretory capacity and can be used as an alternative to (oral) glucose tolerance tests. In this study, we aim to find a predictor model for islet graft function by assessing peak C-peptide after arginine stimulus in the early post-transplantation phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous islet transplantation | – | –Arginine stimulation test: 5 grams of arginine hydrochloride intravenously. Performed at baseline after mixed meal tolerance test (MMTT), performed separately at day -1 or 0, day 1, day 3, day 7 and 3 months, and also at 3 months after MMTT. |
| Allogeneic islet transplantation | – | –Arginine stimulation test: 5 grams of arginine hydrochloride intravenously. Performed at day -1 or 0, day 1, day 3, day 7, 3 months and at 3 months after MMTT. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving allogeneic or autologous islet transplants.
Key inclusion criteria (3 listed)
- Age 16 years or older
- Currently on the LUMC waiting list for allogeneic or autologous islet transplantation
- Willing to use a flash glucose monitoring (FGM) system in the two weeks prior to transplantation
Key exclusion criteria (2 listed)
- Patients who are pregnant
- Patients with known hypersensitivity to arginine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early islet graft function
Time frame: Day 3
Peak C-peptide during AST at day 3
Early islet graft function
Time frame: Month 3
AUC C-peptide during MMTT at 3 months
17 secondary outcomes
Early islet graft function
Time frame: Up to 3 months
Early islet graft function
Time frame: Up to 3 months
Insulin secretory capacity
Time frame: Up to 3 months
Beta-cell death
Time frame: Up to 3 months
Beta-cell death
Time frame: Up to 3 months
Beta-cell death
Time frame: Up to 3 months
Complement factors
Time frame: Up to 3 months
Immunological markers
Time frame: Up to 3 months
Immunological markers
Time frame: Up to 3 months
Beta cell graft function
Time frame: Up to 3 months
Beta cell graft function
Time frame: 3 months
Treatment success
Time frame: 3 months
Beta cell graft function
Time frame: Up to 3 months
Beta cell graft function
Time frame: Up to 3 months
Glycemic control
Time frame: Up to 3 months
Coagulation markers
Time frame: Up to 3 months
Insulin concentration
Time frame: Before the islet transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Islet Cell Transplant for Type 1 Diabetes
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Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes
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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.
Prof. Eelco de Koning principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Islets of Langerhans Transplantation and Diabetes Mellitus, run by Leiden University Medical Center at 1 site in Netherlands.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
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?
Early islet graft function (time frame: Day 3). The study lists 2 primary outcomes in all. 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 6 Jun 2024.