Arginine-stimulated Prediction of Early Outcome After Islet Transplantation

Diabetes Mellitus Clinical Trial

— ALADDIN  

Official title:

Arginine-stimulated Prediction of Early Outcome After Islet Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05540197
• Other study ID #: NL79536.058.22
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2025

Study information

• Verified date: September 2022
• Source: Leiden University Medical Center
• Contact: Prof. Eelco de Koning, MD PhD
• Phone: +31 71 526 2085
• Email: e.j.p.de_koning[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes Mellitus
• Islets of Langerhans Transplantation
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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