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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.