Arginine-stimulated indication of early outcome after islet transplantation

Arginine-stimulated indication of early outcome after islet transplantation - ALADDIN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51657

Enrollment

Registered

2023-01-25

Start date

2023-03-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes diabetes mellitus

Interventions

None listed

Eligibility

Age

16 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged 16 years or older Currently on the waiting list for allogeneic or eligible for autologous islet transplantation Willing to use a flash glucose monitoring (FGM) system in the two weeks prior to transplantation (if not yet using a flash or continuous monitoring system (CGM))

Exclusion criteria

Exclusion criteria: Pregnancy Patients with known hypersensitivity to arginine

Design outcomes

Primary

Measure	Time frame
The primary outcome is the correlation between peak C-peptide after arginine bolus at day 3 post-transplantation and AUC C-peptide after mixed meal tolerance test at 3 months post-transplantation.	—

Secondary

Measure	Time frame
o Stimulation index during in vitro arginine stimulated insulin secretion test o Fasting C-peptide o Fasting glucose o Stimulated C-peptide (during AST and/or MMTT) o AUC C-peptide (during arginine stimulus and/or MMTT) o Concentration of circulating-free insulin deoxyribonucleic acid (DNA) o Insulin concentration in islet product o Complete blood count with differential (e.g. platelets, peripheral mononuclear blood cells (PBMCs)) o T-cell immunophenotype o Plasma-circulating microRNA o Complement factors and markers o Inflammatory cytokines o Coagulation factors and markers o Concentration of secreted peptides by pancreatic islets (e.g. insulin, proinsulin) o Insulin requirements (IU/kg) o HbA1c o Number of severe hypoglycaemic events (SHE) o Flash/continuous glucose monitoring parameters: time in range (% TIR; 3.9 - 10.0 mmol/l); time above range (% TAR; >= 10.0 mmol/l); time below range (% TBR;	—

Measure

Time frame

o Stimulation index during in vitro arginine stimulated insulin secretion test o Fasting C-peptide o Fasting glucose o Stimulated C-peptide (during AST and/or MMTT) o AUC C-peptide (during arginine stimulus and/or MMTT) o Concentration of circulating-free insulin deoxyribonucleic acid (DNA) o Insulin concentration in islet product o Complete blood count with differential (e.g. platelets, peripheral mononuclear blood cells (PBMCs)) o T-cell immunophenotype o Plasma-circulating microRNA o Complement factors and markers o Inflammatory cytokines o Coagulation factors and markers o Concentration of secreted peptides by pancreatic islets (e.g. insulin, proinsulin) o Insulin requirements (IU/kg) o HbA1c o Number of severe hypoglycaemic events (SHE) o Flash/continuous glucose monitoring parameters: time in range (% TIR; 3.9 - 10.0 mmol/l); time above range (% TAR; >= 10.0 mmol/l); time below range (% TBR;

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Countries

Netherlands

Outcome results