Nitrite Infusion in Islet Cell Transplantation

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 2

Conditions: Diabetes

Treatments: Drug: Post-Isolation Infusion; Other: Control; Drug: Pre-Isolation Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03544242

IRB-160901003

Details and patient eligibility

About

This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

Full description

Patients diagnosed with chronic pancreatitis or recurrent acute pancreatitis may acquire insulin-dependent diabetes due to islet cell destruction. Therefore, islet cell autotransplantation is the optimal therapeutic approach for many of these patients. Islet cell autotransplantation is typically done by excision of the pancreas, followed by isolation of the islet cells and then infusion of these cells into the sinusoids of the liver. Isolation of the islet cells occurs in an ischemic and hypoxic environment, resulting in ischemia reperfusion (IR) injury and destruction of islet cells following infusion into the sinusoids. Hence, strategies to prevent IR injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance islet cell survival following reperfusion, also decreasing long-term insulin requirement. The purpose of this study is to determine if NO administered by infusion in patients undergoing islet cell auto transplantation, will inhibit islet cell destruction, increase diabetes cure rate (decrease the amount of and/or the need for long-term insulin requirement), decrease the ischemic injury (reduces the injury to the islet cells from a decrease in oxygen levels during procurement of the islet cells) during islet cell procurement, and decrease IR injury following islet cell infusion. The primary endpoints of the study are exogenous insulin use, HgbA1c levels post-operatively, and blood glucose levels.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients greater than or equal to 18 years of age
• Scheduled to undergo Islet Cell auto-transplantation by Dr. Jared White or Dr. Bart Rose
• Subjects who can provide informed written consent and are willing to do so

Exclusion criteria

-Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 3 patient groups

Control group

Active Comparator group

Treatment:

Other: Control

Pre-Isolation Infusion

Experimental group

Treatment:

Drug: Pre-Isolation Infusion

Post-Isolation Infusion

Experimental group

Treatment:

Drug: Post-Isolation Infusion