Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01053078 · ClinicalTrials.gov registry record · Phase 1
Naltrexone and Hypoglycemia in Type 1 Diabetes
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01053078 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 29 participants.
The verdict
NCT01053078, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death. Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia. The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.
Interventions
- OTHER Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01053078
The ClinicalTrials.gov registry entry for NCT01053078 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 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 Placebo is the first listed.
NCT01053078 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01053078 about?
NCT01053078 is a clinical study titled "Naltrexone and Hypoglycemia in Type 1 Diabetes". Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizur...
What is the current status of trial NCT01053078?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2009-10. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01053078?
The interventions under investigation include: Placebo (OTHER), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01053078?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.