Clinical trial NCT05540197: Arginine-stimulated Indication of Early Outcome After Islet Transplantation
Official title: Arginine-stimulated Indication of Early Outcome After Islet Transplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Islets of Langerhans Transplantation
Diabetes Mellitus
Chronic Pancreatitis
Keywords: total pancreatectomy
autologous islet transplantation
TPIAT
beta-cell function
c-peptide
arginine
mixed meal tolerance test
allogeneic islet transplantation
islet function
ibmir
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving allogeneic or autologous islet transplants.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who are pregnant
* Patients with known hypersensitivity to arginine

Primary outcomes:
measure: Early islet graft function
timeFrame: Day 3
measure: Early islet graft function
timeFrame: Month 3
Secondary outcomes:
measure: Early islet graft function
timeFrame: Up to 3 months
measure: Early islet graft function
timeFrame: Up to 3 months
measure: Insulin secretory capacity
timeFrame: Up to 3 months
measure: Beta-cell death
timeFrame: Up to 3 months
measure: Beta-cell death
timeFrame: Up to 3 months
measure: Beta-cell death
timeFrame: Up to 3 months
measure: Complement factors
timeFrame: Up to 3 months
measure: Immunological markers
timeFrame: Up to 3 months
measure: Immunological markers
timeFrame: Up to 3 months
measure: Beta cell graft function
timeFrame: Up to 3 months
measure: Beta cell graft function
timeFrame: 3 months
measure: Treatment success
timeFrame: 3 months
measure: Beta cell graft function
timeFrame: Up to 3 months
measure: Beta cell graft function
timeFrame: Up to 3 months
measure: Glycemic control
timeFrame: Up to 3 months
measure: Coagulation markers
timeFrame: Up to 3 months
measure: Insulin concentration
timeFrame: Before the islet transplantation
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Prof. Eelco de Koning
role: PRINCIPAL_INVESTIGATOR
References: