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

University of Alabama at Birmingham1 个研究点分布在 1 个国家目标入组 4 人开始时间: 2017年5月7日最近更新: 2020年10月29日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: University of Alabama at Birmingham
入组人数: 4
试验地点: 1
主要终点: Prior to Infusion Blood Glucose Serum Levels

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Care Provider)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

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

研究组 & 干预措施

Control group

Active Comparator

干预措施: Control (Other)

Pre-Isolation Infusion

Experimental

干预措施: Pre-Isolation Infusion (Drug)

Post-Isolation Infusion

Experimental

干预措施: Post-Isolation Infusion (Drug)

结局指标

主要结局

Prior to Infusion Blood Glucose Serum Levels

时间窗: Between the time of induction and the time immediately prior to infusion of either nitrite or saline