MedDataX Logo

Nitrite Infusion in Islet Cell Transplantation

NCT ID: NCT03544242

Last Updated: 2020-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-07

Study Completion Date

2019-06-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

A saline infusion will be administered during the pre-isolation and post-isolation phases.

Pre-Isolation Infusion

Group Type EXPERIMENTAL

Pre-Isolation Infusion

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Post-Isolation Infusion

Intervention Type DRUG

A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control

A saline infusion will be administered during the pre-isolation and post-isolation phases.

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Blair Smith

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Blair Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-160901003

Identifier Type: -

Identifier Source: org_study_id