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Lack of eligible subjects, lack of staffing
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This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator |
| |
| Pre-Isolation Infusion | Experimental |
| |
| Post-Isolation Infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | A saline infusion will be administered during the pre-isolation and post-isolation phases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prior to Infusion Blood Glucose Serum Levels | 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 | 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 | 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 | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
-Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
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| Name | Affiliation | Role |
|---|---|---|
| Blair Smith, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control: A saline infusion will be administered during the pre-isolation and post-isolation phases. |
| FG001 | Pre-Isolation Infusion | 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. |
| FG002 | Post-Isolation Infusion | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control: A saline infusion will be administered during the pre-isolation and post-isolation phases. |
| BG001 | Pre-Isolation Infusion | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prior to Infusion Blood Glucose Serum Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | Between the time of induction and the time immediately prior to infusion of either nitrite or saline |
|
from baseline through 24 months post-operatively
Patients were evaluated for adverse events during appointments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Control: A saline infusion will be administered during the pre-isolation and post-isolation phases. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Sturdivant, MPH | University of Alabama at Birmingham | 205-934-4042 | Adamsturdivant@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2018 | Jul 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Pre-Isolation Infusion | 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 | Drug | A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase. |
|
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 | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | 96 hours post operatively |
| BG002 | Post-Isolation Infusion | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Post-Isolation Infusion | 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. |
|
| Primary | Pre-islet Cell Infusion Blood Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | Five minutes prior to the infusion of islet cells |
|
|
| Primary | 20 Minutes After Islet Cells Blood Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | 20 minutes after the infusion of Islet Cells |
|
|
| Primary | 40 Minutes After Islet Cells Blood Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | 40 minutes after the infusion of Islet Cells |
|
|
| Primary | 24 Hours Post Operative Blood Samples Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | 24 hours post operatively |
|
|
| Primary | 48 Hours Post Operative Blood Samples Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | 48 hours post operatively |
|
|
| Primary | 72 Hours Post Operative Blood Samples Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | 72 hours post operatively |
|
|
| Primary | 96 Hours Post Operative Blood Samples Serum Glucose Levels | Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc. | The study did not reach sufficient enrollment power for statistical analysis. | Posted | 96 hours post operatively |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Pre-Isolation Infusion | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Post-Isolation Infusion | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D006946 | Hyperinsulinism |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |