Chronic Pancreatitis, Diabetes Mellitus, Islets of Langerhans Transplantation
Conditions
Keywords
total pancreatectomy, autologous islet transplantation, TPIAT, beta-cell function, c-peptide, arginine, mixed meal tolerance test, allogeneic islet transplantation, islet function, ibmir
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.
Interventions
None listed
Sponsors
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early islet graft function | Day 3 | Peak C-peptide during AST at day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin secretory capacity | Up to 3 months | Relationship between in vitro secretion and in vivo secretion |
| Beta-cell death | Up to 3 months | Circulating free INS DNA (INS cfDNA) |
| Complement factors | Up to 3 months | Markers of complement activation |
| Immunological markers | Up to 3 months | Peripheral blood mononuclear cell (PBMC) composition |
| Early islet graft function | Up to 3 months | Peak C-peptide during AST and MMTT (other than primary) |
| Treatment success | 3 months | assessed by Igls 2.0 criteria |
| Glycemic control | Up to 3 months | HbA1c (mmol/mol) |
| Coagulation markers | Up to 3 months | Markers indicative for activation of the coagulation cascade |
| Insulin concentration | Before the islet transplantation | Concentration of insulin in the islet product |
| Beta cell graft function | Up to 3 months | Time in range, time below range, time above range as measured by Flash Glucose Monitoring (FGM) or Continuous Glucose Monitoring (CGM) |
Countries
Netherlands
Outcome results
None listed