Arginine-stimulated Indication of Early Outcome After Islet Transplantation

NCT05540197 | Enrolling By Invitation

• 1 other identifier: NL79536.058.22
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Islets of Langerhans Transplantation; Diabetes Mellitus; Chronic Pancreatitis

Keywords

total pancreatectomy; autologous islet transplantation; TPIAT; beta-cell function; c-peptide; arginine; mixed meal tolerance test; allogeneic islet transplantation; islet function; ibmir

Outcome Measures

Primary Outcomes (2)

• Early islet graft function

  Peak C-peptide during AST at day 3

  Day 3

• Early islet graft function

  AUC C-peptide during MMTT at 3 months

  Month 3

Secondary Outcomes (17)

• Early islet graft function

  Up to 3 months

• Early islet graft function

  Up to 3 months

• Insulin secretory capacity

  Up to 3 months

• Beta-cell death

  Up to 3 months

• Beta-cell death

  Up to 3 months

Study Arms (2)

Autologous islet transplantation

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

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving allogeneic or autologous islet transplants.

You may qualify if:

• 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

You may not qualify if:

• Patients who are pregnant
• Patients with known hypersensitivity to arginine

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma to analyse circulating free DNA, microRNA, T-cell phenotype. Blood cell composition.

MeSH Terms

Conditions

Diabetes Mellitus; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Eelco de Koning

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Eelco de Koning

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: February 23, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

NL (1)