NCT05540197

Arginine-stimulated Indication of Early Outcome After Islet Transplantation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Islets of Langerhans Transplantation
• Diabetes Mellitus
• Chronic Pancreatitis

Timeline

• Start date: 2023-02-23
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-09-14
• Last updated: 2024-06-06

Locations

1 site across 1 country: Netherlands