Nitrite Infusion in Islet Cell Transplantation
2020年10月7日 更新者: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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
4
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:控制组
|
A saline infusion will be administered during the pre-isolation and post-isolation phases.
|
实验性的: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.
|
实验性的: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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Prior to Infusion Blood Glucose Serum Levels
大体时间: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
大体时间: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
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20 Minutes After Islet Cells Blood Serum Glucose Levels
大体时间:20 minutes after the infusion of Islet Cells
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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
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40 Minutes After Islet Cells Blood Serum Glucose Levels
大体时间:40 minutes after the infusion of Islet Cells
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Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
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40 minutes after the infusion of Islet Cells
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24 Hours Post Operative Blood Samples Serum Glucose Levels
大体时间:24 hours post operatively
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Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
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24 hours post operatively
|
48 Hours Post Operative Blood Samples Serum Glucose Levels
大体时间: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
大体时间: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
大体时间:96 hours post operatively
|
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
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96 hours post operatively
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Blair Smith, MD、University of Alabama at Birmingham
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年5月7日
初级完成 (实际的)
2019年6月27日
研究完成 (实际的)
2019年6月27日
研究注册日期
首次提交
2018年5月21日
首先提交符合 QC 标准的
2018年5月21日
首次发布 (实际的)
2018年6月1日
研究记录更新
最后更新发布 (实际的)
2020年10月29日
上次提交的符合 QC 标准的更新
2020年10月7日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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