DiabetesPhase 2NCT03544242
Nitrite Infusion in Islet Cell Transplantation
A Phase 2 study testing Pre-Isolation Infusion and Post-Isolation Infusion in people with Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Pre-Isolation Infusion and Post-Isolation Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2017to 27 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Control, Pre-Isolation Infusion, Post-Isolation Infusion
- Keywords
- Diabetes, Insulin Resistance, Nitrite, Pancreatic islet cells, Autotransplantation, Ischemia reperfusion injury, Mitigation, Cure, Nitric oxide, Sodium nitrite, Islet cell, Survival, Pancreas, Liver
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
A saline infusion will be administered during the pre-isolation and post-isolation phases.
Pre-Isolation InfusionDrug
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 InfusionDrug
A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: Control |
| Pre-Isolation Infusion | Experimental | Not described Receives: Drug: Pre-Isolation Infusion |
| Post-Isolation Infusion | Experimental | Not described Receives: Drug: Post-Isolation Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 hours post operatively
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.
Measured: 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.
Measured: 96 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start7 May 2017
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Why it stopped: Lack of eligible subjects, lack of staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blair Smith, University of Alabama at Birmingham
- Investigators
- Blair Smith, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544242
- Sponsor's protocol ID
- IRB-160901003
- Status last verified
- Oct 2020
- First submitted
- 21 May 2018
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrite Infusion in Islet Cell Transplantation: Test of Clinical Efficacy and Determination of Cytoprotective Mechanisms
- ClinicalTrials.gov ID
- NCT03544242
- Acronym / sponsor ID
- IRB-160901003
- Conditions
- Diabetes
- Keywords
- Diabetes, Insulin Resistance, Nitrite, Pancreatic islet cells, Autotransplantation, Ischemia reperfusion injury, Mitigation, Cure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible subjects, lack of staffing
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 May 2017 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control |
| Pre-Isolation Infusion | Experimental | Drug: Pre-Isolation Infusion |
| Post-Isolation Infusion | Experimental | Drug: Post-Isolation Infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlA saline infusion will be administered during the pre-isolation and post-isolation phases. | Other | Control group |
| Pre-Isolation InfusionA nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase. | Drug | Pre-Isolation Infusion |
| Post-Isolation InfusionA saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase. | Drug | Post-Isolation Infusion |
Primary outcome
Prior to Infusion Blood Glucose Serum Levels
Time frame: 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.
Pre-islet Cell Infusion Blood Serum Glucose Levels
Time frame: 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.
20 Minutes After Islet Cells Blood Serum Glucose Levels
Time frame: 20 minutes after the infusion of Islet Cells
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
40 Minutes After Islet Cells Blood Serum Glucose Levels
Time frame: 40 minutes after the infusion of Islet Cells
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
24 Hours Post Operative Blood Samples Serum Glucose Levels
Time frame: 24 hours post operatively
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
48 Hours Post Operative Blood Samples Serum Glucose Levels
Time frame: 48 hours post operatively
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
72 Hours Post Operative Blood Samples Serum Glucose Levels
Time frame: 72 hours post operatively
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
96 Hours Post Operative Blood Samples Serum Glucose Levels
Time frame: 96 hours post operatively
Blood serum glucose levels will be measured from a blood sample of the amount of 3-5 cc.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blair Smith, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pre-Isolation Infusion and Post-Isolation Infusion in people with Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prior to Infusion Blood Glucose Serum Levels (time frame: Between the time of induction and the time immediately prior to infusion of either nitrite or saline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.