| Trial ID: | L5555 |
| Source ID: | NCT03149770
|
| Associated Drug: |
Naloxone Then Placebo
|
| Title: |
Naloxone, Hypoglycemia and Exercise
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03149770/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Naloxone then placebo|DRUG: Placebo then Naloxone
|
| Outcome Measures: |
Primary: Change in Symptom Score, The primary outcome variable for Aim 1 will be the difference, naloxone vs. saline, in symptom scores collected using a standard questionnaire during the hypoglycemic clamp on Day 2, after administration of intranasal treatment during exercise on Day 1. the scale for symptoms score is 0-72. A higher score represents a better outcome., Day 2|Change in Epinephrine Levels, The primary outcome variable for Aim 2 will be the difference, naloxone vs. saline, in peak epinephrine levels measured during the hypoglycemic clamp on Day 2, after administration of treatment during exercise on Day 1., Day 2 |
|
| Sponsor/Collaborators: |
Sponsor: University of Minnesota
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-18
|
| Completion Date: |
2023-04-01
|
| Results First Posted: |
2024-04-16
|
| Last Update Posted: |
2024-04-16
|
| Locations: |
University of Minnesota, Minneapolis, Minnesota, 55455, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03149770
|
