Nitrite Infusion in Islet Cell Transplantation

October 7, 2020 updated by: Blair Smith, University of Alabama at Birmingham

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Other: Control
A saline infusion will be administered during the pre-isolation and post-isolation phases.
Experimental: Pre-Isolation Infusion
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.
Experimental: Post-Isolation Infusion
Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Blair Smith, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2017

Primary Completion (Actual)

June 27, 2019

Study Completion (Actual)

June 27, 2019

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

May 21, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-160901003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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