Arginine-stimulated Indication of Early Outcome After Islet Transplantation

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

• Registration Number: NCT05540197
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Study Start: 2023-02-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early islet graft function	Month 3	AUC C-peptide during MMTT at 3 months

Secondary Outcome Measures

Name	Time	Method
Coagulation markers	Up to 3 months	Markers indicative for activation of the coagulation cascade
Beta cell graft function	Up to 3 months	Insulin requirements (IU/kg/day)
Treatment success	3 months	assessed by Igls 2.0 criteria
Insulin concentration	Before the islet transplantation	Concentration of insulin in the islet product
Early islet graft function	Up to 3 months	AUC C-peptide during AST and MMTT (other than primary)
Insulin secretory capacity	Up to 3 months	Relationship between in vitro secretion and in vivo secretion
Complement factors	Up to 3 months	Markers of complement activation
Glycemic control	Up to 3 months	HbA1c (mmol/mol)
Beta-cell death	Up to 3 months	Plasma circulating microRNA
Immunological markers	Up to 3 months	T-cell phenotyping

Trial Locations

Locations (1)

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands