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NCT03149770 · ClinicalTrials.gov registry record · Phase 2
Naloxone, Hypoglycemia and Exercise
A Phase 2 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03149770 is a Phase 2 study that has completed, run by University of Minnesota. The registered enrollment target is 30 participants.
The verdict
NCT03149770, a Phase 2 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The overall objective of this project is to determine if the intranasal administration of naloxone during exercise will be a novel approach to preserve the counterregulatory response to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced autonomic failure contributes to the development of impaired awareness of hypoglycemia. Treatments that blunt the consequences of exercise induced autonomic failure, such as preserving the post-exercise counterregulatory response to hypoglycemia, may improve awareness of hypoglycemia. Naloxone, an opioid antagonist, is an extremely promising agent. In healthy volunteers, intravenous administration of naloxone during exercise preserved the counterregulatory response to hypoglycemia the following day (1). In this study, investigators will extend the clinical applicability by administering intranasal naloxone to individuals with type 1 diabetes. Specifically, the investigators will use a randomized, placebo controlled, crossover design to administer drug or placebo to patients with type 1 diabetes during acute exercise and assess the counterregulatory response to hypoglycemia the following day. The use of intranasal naloxone is a highly innovative aspect of this proposal. Intranasal naloxone translates readily to clinical use and, as demonstrated by the investigators preliminary data, achieves similar plasma drug concentrations as after IV administration.
Interventions
- DRUG Naloxone then placebo
- DRUG Placebo then Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2023-04-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03149770
The ClinicalTrials.gov registry entry for NCT03149770 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Naloxone then placebo is the first listed.
NCT03149770 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03149770 about?
NCT03149770 is a clinical study titled "Naloxone, Hypoglycemia and Exercise". The overall objective of this project is to determine if the intranasal administration of naloxone during exercise will be a novel approach to preserve the counterregulatory response to hypoglycemia experienced the next day in patients with type 1 diabetes. Exercise induced autonomic failure contrib...
What is the current status of trial NCT03149770?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2017-09-18. Estimated completion is 2023-04-01.
What interventions are being tested in trial NCT03149770?
The interventions under investigation include: Naloxone then placebo (DRUG), Placebo then Naloxone (DRUG).
Who is sponsoring clinical trial NCT03149770?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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