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 Type
OBSERVATIONAL
Enrollment
30
Leiden University Medical Center
Leiden, South Holland, Netherlands
Early islet graft function
Peak C-peptide during AST at day 3
Time frame: Day 3
Early islet graft function
AUC C-peptide during MMTT at 3 months
Time frame: Month 3
Early islet graft function
Peak C-peptide during AST and MMTT (other than primary)
Time frame: Up to 3 months
Early islet graft function
AUC C-peptide during AST and MMTT (other than primary)
Time frame: Up to 3 months
Insulin secretory capacity
Relationship between in vitro secretion and in vivo secretion
Time frame: Up to 3 months
Beta-cell death
Circulating free INS DNA (INS cfDNA)
Time frame: Up to 3 months
Beta-cell death
insulin - proinsulin ratio
Time frame: Up to 3 months
Beta-cell death
Plasma circulating microRNA
Time frame: Up to 3 months
Complement factors
Markers of complement activation
Time frame: Up to 3 months
Immunological markers
Peripheral blood mononuclear cell (PBMC) composition
Time frame: Up to 3 months
Immunological markers
T-cell phenotyping
Time frame: 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)
Time frame: Up to 3 months
Beta cell graft function
assessed by Igls 2.0 criteria
Time frame: 3 months
Treatment success
assessed by Igls 2.0 criteria
Time frame: 3 months
Beta cell graft function
Amount of severe hypoglycaemic events
Time frame: Up to 3 months
Beta cell graft function
Insulin requirements (IU/kg/day)
Time frame: Up to 3 months
Glycemic control
HbA1c (mmol/mol)
Time frame: Up to 3 months
Coagulation markers
Markers indicative for activation of the coagulation cascade
Time frame: Up to 3 months
Insulin concentration
Concentration of insulin in the islet product
Time frame: Before the islet transplantation
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