Conditions: Diabetes
Keywords: Diabetes Insulin Resistance Nitrite Pancreatic islet cells Autotransplantation Ischemia reperfusion injury Mitigation Cure Nitric oxide Sodium nitrite Islet cell Survival Pancreas Liver
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

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

Detailed 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Control intervention 2: Pre-Isolation Infusion intervention 3: Post-Isolation Infusion
Intervention descriptions: intervention 1: A saline infusion will be administered during the pre-isolation and post-isolation phases. intervention 2: A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase. intervention 3: A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.

Protocol document:
Prot_SAP_000.pdf: