Clinical trial NCT03544242: Nitrite Infusion in Islet Cell Transplantation
Official title: Nitrite Infusion in Islet Cell Transplantation: Test of Clinical Efficacy and Determination of Cytoprotective Mechanisms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prior to Infusion Blood Glucose Serum Levels
timeFrame: Between the time of induction and the time immediately prior to infusion of either nitrite or saline
measure: Pre-islet Cell Infusion Blood Serum Glucose Levels
timeFrame: Five minutes prior to the infusion of islet cells
measure: 20 Minutes After Islet Cells Blood Serum Glucose Levels
timeFrame: 20 minutes after the infusion of Islet Cells
measure: 40 Minutes After Islet Cells Blood Serum Glucose Levels
timeFrame: 40 minutes after the infusion of Islet Cells
measure: 24 Hours Post Operative Blood Samples Serum Glucose Levels
timeFrame: 24 hours post operatively
measure: 48 Hours Post Operative Blood Samples Serum Glucose Levels
timeFrame: 48 hours post operatively
measure: 72 Hours Post Operative Blood Samples Serum Glucose Levels
timeFrame: 72 hours post operatively
measure: 96 Hours Post Operative Blood Samples Serum Glucose Levels
timeFrame: 96 hours post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Blair Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: