Arginine-stimulated Indication of Early Outcome After Islet Transplantation (ALADDIN)

Leiden University Medical Center (LUMC)

Status: Invitation-only

Conditions: Chronic Pancreatitis; Islets of Langerhans Transplantation; Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT05540197

NL79536.058.22

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Autologous islet transplantation

Description:

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

Description:

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.