TerminatedPhase 2

Nitrite Infusion in Islet Cell Transplantation

Stopped: Lack of eligible subjects, lack of staffing

United States4 participantsStarted 2017-05-07

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prior to Infusion Blood Glucose Serum Levels

Timeframe: 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

Timeframe: Five minutes prior to the infusion of islet cells

20 Minutes After Islet Cells Blood Serum Glucose Levels

Timeframe: 20 minutes after the infusion of Islet Cells

40 Minutes After Islet Cells Blood Serum Glucose Levels

Timeframe: 40 minutes after the infusion of Islet Cells

24 Hours Post Operative Blood Samples Serum Glucose Levels

Timeframe: 24 hours post operatively

48 Hours Post Operative Blood Samples Serum Glucose Levels

Timeframe: 48 hours post operatively

72 Hours Post Operative Blood Samples Serum Glucose Levels

Timeframe: 72 hours post operatively

Trial details

NCT IDNCT03544242

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-27

Results submitted2020-08-03

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