Nitrite Infusion in Islet Cell Transplantation

Diabetes Clinical Trial

Official title:

Nitrite Infusion in Islet Cell Transplantation: Test of Clinical Efficacy and Determination of Cytoprotective Mechanisms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03544242
• Other study ID #: IRB-160901003
• Status: Terminated
• Phase: Phase 2
• Start date: May 7, 2017
• Est. completion date: June 27, 2019

Study information

• Verified date: October 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Control
A saline infusion will be administered during the pre-isolation and post-isolation phases.

Drug:
• Pre-Isolation Infusion
A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
• Post-Isolation Infusion
A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prior to Infusion Blood Glucose Serum Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	Between the time of induction and the time immediately prior to infusion of either nitrite or saline
Primary	Pre-islet Cell Infusion Blood Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	Five minutes prior to the infusion of islet cells
Primary	20 Minutes After Islet Cells Blood Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	20 minutes after the infusion of Islet Cells
Primary	40 Minutes After Islet Cells Blood Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	40 minutes after the infusion of Islet Cells
Primary	24 Hours Post Operative Blood Samples Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	24 hours post operatively
Primary	48 Hours Post Operative Blood Samples Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	48 hours post operatively
Primary	72 Hours Post Operative Blood Samples Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	72 hours post operatively
Primary	96 Hours Post Operative Blood Samples Serum Glucose Levels	Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.	96 hours post operatively