Nitrite Infusion in Islet Cell Transplantation

Phase 2

Terminated

• Conditions: Diabetes
• Interventions: Other: Control; Drug: Pre-Isolation Infusion; Drug: Post-Isolation Infusion

• Registration Number: NCT03544242
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2017-05-07
• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-06-01
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-27
• Results First Submitted: 2020-08-03
• Results First Submitted QC: 2020-08-03
• Results First Posted: 2020-08-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control	-
Pre-Isolation Infusion	Pre-Isolation Infusion	-
Post-Isolation Infusion	Post-Isolation Infusion	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States